Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 description, usages, side effects, indications, overdosage, supplying and lots more!

Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30

OMP, INC.

  • 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
Obagi 360™ HydraFactor Moisturizing Cream with Sunscreen Broad Spectrum SPF 30SUNSCREEN

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose

Avobenzone 1%

Sunscreen

Octinoxate 7.5%

Sunscreen

Octisalate 5%

Sunscreen

Oxybenzone 5%

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

Directions

  • •apply liberally 15 minutes before sun exposure
  • •use a water resistant sunscreen 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 a.m.–2 p.m.
    • •wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, butyloctyl salicylate, C12-15 alkyl benzoate, caesalpinia spinosa gum, caprylyl glycol, carbomer, dextrin, disodium EDTA, eperua falcata bark extract, ethylhexylglycerin, glycerin, hexylene glycol, hydrolyzed caesalpinia spinosa gum, phenoxyethanol, pichia/resveratrol ferment extract, polysorbate 20, sodium hyaluronate, sodium hydroxide, sorbitan oleate, tocopheryl acetate, ubiquinone, water

Other information

  • •store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • •protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Distributed by OMP, Inc.,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 75 g Tube Carton

OBAGI®
MEDICAL

OBAGI360

HydraFactor
Moisturizing Cream
with Sunscreen

Broad Spectrum
SPF 30

Net wt. 2.5 oz. (75 g)

Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30

AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62032-300
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 10 mg
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 50 mg
OXYBENZONE OXYBENZONE 50 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
BUTYLOCTYL SALICYLATE
ALKYL (C12-15) BENZOATE
CAESALPINIA SPINOSA RESIN
CAPRYLIC ALCOHOL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
Icodextrin
EDETATE DISODIUM
EPERUA FALCATA BARK
ETHYLHEXYLGLYCERIN
GLYCERIN
Hexylene Glycol
PHENOXYETHANOL
POLYSORBATE 20
HYALURONATE SODIUM
SODIUM HYDROXIDE
SORBITAN MONOOLEATE
.ALPHA.-TOCOPHEROL ACETATE
UBIDECARENONE
water

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 75 in 1 TUBE
2 NDC:62032-300-37 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-01-02


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