Label: REVITALIZING MOISTURIZING SUNSCREEN SPF 20- octocrylene and octinoxate and avobenzone 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 22, 2013

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  • Active ingredient

    OCTOCRYLENE 10.0%

    OCTINOXATE 7.5%

    AVOBENZONE 3.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    For external use only.

    Do not apply to

    • irritated or broken skin.
  • Warnings

    Consult a doctor

    • Stop use and consult a doctor if rash occurs.
  • Warnings

    Stop use

    • Stop use and consult a doctor if rash occurs
  • Keep Out of Reach of Children.

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

  • Directions

    • Gently massage onto all areas of the face using a circular motion 15 minutes prior

      to sun exposure

    • Reapply every two hours
    • For children under 6 months of age, ask a doctor
    • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.
  • Other Information

    • protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    Water (AQUA, EAU), Helianthus Annuus Seed Oil, Cetearyl Alcohol, Limnanthes Alba, Carthamus Tinctorius (SAFFLOWER) Seed Oil, Meadowfoam Estolide, Polysorbate-60, Crambe Abyssinica Seed Oil, Simmondsia Chinesis (JOJOBA) Seed Oil, Meadowfoam Delta-Lactone, Olea Europaea (OLIVE) Oil Unsaponifiables, PEG-40 Hydrogenated Castor Oil, Meadowfoamamidopropyl Betaine, Dimethicone PEG-8 Meadowfoamate, Steareth-20, Polysorbate-65, Phenoxyethanol, Carbomer, Panthenol, Phytosterol, Aminomethylpropanol, CI15985 (YELLOW 6), Tocopheryl Acetate, Fragrance (Parfum), Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Cholecalciferol, Calendula Officinalis Flower Extract, Anthemis Nobilis (CHAMOMILE) Flower Extract, Beta Sitosterol, Tripeptide-10 Citrulline, Ubiquinone Q10, Sea Salt, Glycine Soja (Soybean) Oil, Oenothera Biennis (EVENING PRIMROSE) Oil (OMEGA-3), Borago Officinalis (BORAGE) Seed Oil (OMEGA-6), Aloe Barbadensis Leaf Juice, Algae Extract, Hippophae Rhamnoides (SEA BUCKTHORN) Extract. PARABEN-FREE

  • Package/Label Principal Display Panel

    DARK & BEAUTY REVITALIZING MOISTURIZING CREAM SPF-20

    Manufactured for and exclusively distributed by:

    Genome Cosmetics LLC

    Bensalem, PA 19020 USA

    Made in the U.S.A

    Age Control Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    REVITALIZING MOISTURIZING SUNSCREEN SPF 20 
    octocrylene and octinoxate and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61791-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    MEADOWFOAM SEED OIL FATTY ACIDS (UNII: MK2D1PBV6N)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MEADOWLACTONE (UNII: 3OY5Q13U9R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POLYSORBATE 65 (UNII: 14BGY2Y3MJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    TRIPEPTIDE-10 CITRULLINE (UNII: 2732R0E76W)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    SEA SALT (UNII: 87GE52P74G)  
    GLYCINE (UNII: TE7660XO1C)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    BORAGE OIL (UNII: F8XAG1755S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NORI (UNII: 477TV3P5UX)  
    HIPPOPHAE RHAMNOIDES FRUIT JUICE (UNII: UC3P08EB3Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61791-126-011 in 1 CARTON
    150 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/02/2015
    Labeler - GENOME COSMETICS, LLC (013538977)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA, LLC079103999manufacture(61791-126)
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