Solar Protection Formula SPF 65 description, usages, side effects, indications, overdosage, supplying and lots more!

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Solar Protection Formula SPF 65

Fallien Cosmeceuticals, LTD.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredients:

Octinoxate 6%

Octocrylene 7%

Oxybenzone 4%

Titanium Dioxide 4%

Zinc Oxide 5%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SHAKE WELL BEFORE USING

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant product if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, 5-Bromo-5-Nitro-1, 3-Dioxane, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Dimethicone, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Selenium Yeast Extract, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Solar Protection Formula combines Titanium Dioxide, Zinc Oxide, and Iron Oxide to form a complete wall of reflection against UVA/UVB damage.

Manufactured exclusively for
Fallien Ltd., West Norriton, PA
Made in USA

Principal Display Panel – 2 oz Carton Label

NDC 58892-265-59

SOLAR

PROTECTION

FORMULA ®

Oil Free

Non-comedogenic

SPF 65

Broad Spectrum

UVA/UVB

2 Fl. Oz. / 58.8ml

Solar Protection Formula SPF 65

Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58892-265
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 60 mg
OCTOCRYLENE Octocrylene 70 mg
OXYBENZONE OXYBENZONE 40 mg
titanium dioxide 40 mg
Zinc Oxide Zinc oxide 50 mg

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
ALUMINUM STARCH OCTENYLSUCCINATE
ASCORBYL PALMITATE
5-Bromo-5-Nitro-1,3-Dioxane
.BETA.-CAROTENE
BUTYLPARABEN
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
DIMETHICONE
EDETATE DISODIUM
ferric oxide red
isobutylparaben
ISOPROPYLPARABEN
Linoleamidopropyl Dimethylamine
OCTYLDODECYL NEOPENTANOATE
PHENOXYETHANOL
MARITIME PINE
POLYSORBATE 20
propylene glycol
SORBITAN MONOLAURATE
talc
Tocopherol
.ALPHA.-TOCOPHEROL ACETATE
TRIETHOXYCAPRYLYLSILANE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 58.8 in 1 BOTTLE
2 NDC:58892-265-59 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2004-01-02


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