GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30 SUNSCREEN- homosalate, octinoxate, octocrylene, and zinc oxide cream

GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30 by

Drug Labeling and Warnings

GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30 by is a Otc medication manufactured, distributed, or labeled by Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC., LABORATOIRE DR RENAUD INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Homosalate 12%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octocrylene 2%	Sunscreen
Zinc Oxide 4.9%	Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

Inactive ingredients

aluminum starch octenylsuccinate, behentrimonium methosulfate, boron nitride, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetearyl alcohol, cholesterol, dimethicone, disodium EDTA, ethoxydiglycol, glycerin, hydroxyethylcellulose, kinetin, methylparaben, niacinamide, PEG-12 glyceryl dimyristate, phytosphingosine, propylparaben, sodium hyaluronate, sodium lauroyl lactylate, water, xanthan gum, zeatin

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

OBAGI®
MEDICAL

Gentle Rejuvenation
Ultra-Light Repair
SPF 30
Sunscreen Cream

Hypoallergenic
Non-comedogenic

Net wt. 1.7 oz. (50 g)

INGREDIENTS AND APPEARANCE

GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30  SUNSCREEN
homosalate, octinoxate, octocrylene, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	120 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
BORON NITRIDE (UNII: 2U4T60A6YD)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIMETHICONE 100 (UNII: RO266O364U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
KINETIN (UNII: P39Y9652YJ)
METHYLPARABEN (UNII: A2I8C7HI9T)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ZEATIN (UNII: 7I6OOJ9GR6)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-131-70	1 in 1 CARTON
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/15/2013

Labeler - Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRE DR RENAUD INC.		202501565	MANUFACTURE(62032-131) , LABEL(62032-131) , PACK(62032-131)