01 Moisture Foundation SPF 15 description, usages, side effects, indications, overdosage, supplying and lots more!

01 Moisture Foundation SPF 15

The Body Shop Wake Forest

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
moisture foundation SPF 15

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients Purpose
Octinoxate (7.5%), Sunscreen
Zinc Oxide (7.80%). Sunscreen

Uses

  • helps prevent sunburn.
  • higher SPF gives more protection.

Warning

  • For external use only.

When using this product

  • keep out of eyes.

Rinse with water to remove.

Stop and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply evenly before sun exposure and as needed.
  • for use in children under 6 months old, ask a doctor.
  • shake well before use.

Inactive Ingredients

Water, Cyclomethicone, Propylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Dextrin Palmitate, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Isopropyl Lanolate, Sclerocarya Birrea (Marula) Oil, Phenoxyethanol, Polyethylene, Sodium Chloride, Beeswax, Boron Nitride, Ethylene Brassylate, Glycerin, Tocopheryl Acetate, Methylparaben, PEG-40 Hydrogenated Castor Oil, Hectorite, Phenyl Methicone, Xanthan Gum, Propylparaben, Triethoxycaprylylsilane, Sodium Hyaluronate, Pyrus Malus (Apple) Extract, Ethylparaben, Butylparaben, Isobutylparaben, Titanium Dioxide, Iron Oxides.

© 2008 THE BODY SHOP INT'L PLC, BN17 6LS, UK.

MADE IN USA DIST:THE BODY SHOP WAKE FOREST,
NC 27587, USA; ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com

PRINCIPAL DISPLAY PANEL - 30 mL label

THE BODY SHOP®

MOISTURE FOUNDATION
SPF 15
FOND DE TEINT HYDRATANT
IND 15

30 mL
(1.0 US FL OZ)

PRINCIPAL DISPLAY PANEL - 30 mL label

PRINCIPAL DISPLAY PANEL - 01 bottle label

01 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821578
SKU: 83161

PRINCIPAL DISPLAY PANEL - 01 bottle label

PRINCIPAL DISPLAY PANEL - 02 bottle label

02 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821579
SKU: 83107

PRINCIPAL DISPLAY PANEL - 02 bottle label

PRINCIPAL DISPLAY PANEL - 03 bottle label

03 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821580
SKU: 83108

PRINCIPAL DISPLAY PANEL - 03 bottle label

PRINCIPAL DISPLAY PANEL - 04 bottle label

04 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821581
SKU: 83109

PRINCIPAL DISPLAY PANEL - 04 bottle label

PRINCIPAL DISPLAY PANEL - 05 bottle label

05 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821582
SKU: 83110

PRINCIPAL DISPLAY PANEL - 05 bottle label

PRINCIPAL DISPLAY PANEL - 06 bottle label

06 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821583
SKU: 83112

PRINCIPAL DISPLAY PANEL - 06 bottle label

PRINCIPAL DISPLAY PANEL - 07 bottle label

07 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821584
SKU: 83113

PRINCIPAL DISPLAY PANEL - 07 bottle label

PRINCIPAL DISPLAY PANEL - 08 bottle label

08 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821585
SKU: 83162

PRINCIPAL DISPLAY PANEL - 08 bottle label

01 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-161
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-161-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


02 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-107
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-107-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


03 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-108
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-108-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


04 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-109
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-109-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


05 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-110
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-110-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


06 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-112
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-112-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


07 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-113
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-113-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


08 Moisture Foundation SPF 15

Octinoxate and Zinc Oxide EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57691-162
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 mg
Zinc Oxide Zinc oxide 3.9 mg

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-162-30 30 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-09-06


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Be sure to consult your doctor before taking any medication!
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