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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated October 15, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose

    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)

    Principal Display Panel - 50 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30  SUNSCREEN
    homosalate, octinoxate, octocrylene, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE49 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-131-701 in 1 CARTON
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/15/2013
    Labeler - Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRE DR RENAUD INC.202501565MANUFACTURE(62032-131) , LABEL(62032-131) , PACK(62032-131)
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