OTC Medication Information: Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREEN

OBAGI 360 HYDRAFACTOR MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, octinoxate, octisalate and oxybenzone cream
OBAGI COSMECEUTICAL LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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. If product gets into 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
  • 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
  • children under 6 months: Ask a doctor

Other information

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

Inactive ingredients

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

Questions or comments?

1.800.636.7546

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

Distributed by Obagi Cosmeceuticals LLC,
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)

Principal Display Panel -- 75 g Tube Carton
(click image for full-size original)
OBAGI 360 HYDRAFACTOR MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, octinoxate, octisalate, and oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 10 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 50 mg in 1 g
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 Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-300-37 1 TUBE in 1 CARTON contains a TUBE
1 75 g in 1 TUBE This package is contained within the CARTON (62032-300-37)
2 NDC:62032-300-09 1 TUBE in 1 CARTON contains a TUBE
2 75 g in 1 TUBE This package is contained within the CARTON (62032-300-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/02/2014
Labeler — OBAGI COSMECEUTICAL LLC (790553353)
Establishment
Name Address ID/FEI Operations
G.S Cosmeceutical 017014734 MANUFACTURE (62032-300), LABEL (62032-300), PACK (62032-300)

Revised: 09/2019 OBAGI COSMECEUTICAL LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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