Label: AGE DEFYING HYDRATING SUNSCREEN SPF 30- avobenzone octinoxate octisalate oxybenzone homosalate octocrylene lotion

  • 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 December 20, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    AVOBENZONE 3%, HOMOSALATE 7%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 3%, OXYBENZONE 6%

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  • PURPOSE

    PURPOSE:

    SUNSCREEN

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  • INDICATIONS & USAGE

    USES:

    MULTI-ACTION FORMULA PROVIDES FULL-SPECTRUM UV AND ENVIRONMENTAL PROTECTION, WHILE RESTORING CRITICAL MOISTURE AND SKIN'S TIGHTNESS.

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  • WARNINGS

    WARNINGS:

    FOR EXTERNAL USE ONLY.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • OTHER SAFETY INFORMATION

    AVOID CONTACT WITH  EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

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  • STOP USE

    IF IRRITATION DEVELOPS, DISCONTINUE USE.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    APPLY AS LAST STEP IN MORNING ROUTINE OR BEFORE SUN EXPOSURE. REAPPLY AS NEEDED AFTER SWIMMING, PERSPIRING, OR TOWEL DRYING. AVOID APPLICATION NEAR EYE AREA.

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  • INACTIVE INGREDIENT

    WATER, TAPIOCA STARCH, SD ALCOHOL 40, C12-15 ALKYL BENZOATE, DIPROPYLENE GLYCOL DIBENZOATE, PPG-15 STEARYL ETHER BENZOATE, BUTYLOCTYL SALICYLATE, CYCLOMETHICONE, PEG/PPG-18/18 DIMETHICONE, SILICA, VP/HEXADECENE COPOLYMER, ALOE BARBADENSIS LEAF JUICE, ALGAE EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, TOCOPHEROL, DIMETHICONE, POLYSORBATE 80, ISOSTEARIC ACID, TRIETHANOLAMINE, TETRASODIUM EDTA, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PHENOXYETHANOL, CAPRYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL.

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  • QUESTIONS

    QUESTIONS? +1-760-268-0047

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  • PRINCIPAL DISPLAY PANEL

    SKIN AUTHORITY

    AGE DEFYING HYDRATING SUNSCREEN

    150 ML / 5.1 FL OZ

    51136(revA)150ml-AgeDefyingHydratingSunscreen


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  • INGREDIENTS AND APPEARANCE
    AGE DEFYING HYDRATING SUNSCREEN  SPF 30
    avobenzone octinoxate octisalate oxybenzone homosalate octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46007-201
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46007-201-25 150 mL in 1 TUBE; Type 0: Not a Combination Product 04/19/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 04/19/2012
    Labeler - Skin Authority LLC (136549396)
    Registrant - Skin Authority LLC (136549396)
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