Label: AGE DEFYING MOISTURIZER SPF 18- avobenzone octinoxate octisalate oxybenzone 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 2%, OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 6%

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  • PURPOSE

    PURPOSE:

    SUNSCREEN

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  • INDICATIONS & USAGE

    USES: ANTI-AGING COMPLEX WITH FULL-SPECTRUM SUN PROTECTION.

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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 AND EYELIDS. 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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  • OTHER INGREDIENTS:

    WATER, TETRAHEXYLDECYL ASCORBATE (VITAMIN C ESTER), TOCOPHERYL ACETATE (VITAMIN E ACETATE), C12-15 ALKYL BENZOATE, DIPROPYLENE GLYCOL DIBENZOATE, DIPALMITOYL HYDROXYPROLINE, PPG-15 STEARYL ETHER BENZOATE, BUTYLOCTYL SALICYLATE, CETYL PHOSPHATE, SILICA, ALOE BARBADENSIS JUICE, ALGAE EXTRACT, GLYCERIN, PHENYL TRIMETHICONE, CYCLOMETHICONE, POLYSILICONE-11, LECITHIN, PALMITOYL HYDROLYZED WHEAT PROTEIN, CETEARYL ALCOHOL, GLYCERYL STEARATE, STEARIC ACID, SODIUM HYALURONATE, PPG-5-CETETH-10 PHOSPHATE, CENTELLA ASIATICA (HYDOCOTYL) EXTRACT, ECHINACEA PURPUREA (CONEFLOWER) EXTRACT, BUTYLENE GLYCOL, PANTHENOL (PROVITAMIN B5), SQUALANE, ALLANTOIN, TOCOPHERYL LINOLEATE (VITAMIN E LINOLEATE), RETINYL PALMITATE (VITAMIN A PALMITATE), PANCIUM MILICAEUM (MILLET) SEED EXTRACT, ZEA MAYS (CORN) OIL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, PHENOXYETHANOL, CAPRYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL.

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  • QUESTIONS

    QUESTIONS? +1-760-268-0047

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  • INGREDIENTS AND APPEARANCE
    AGE DEFYING MOISTURIZER  SPF 18
    avobenzone octinoxate octisalate oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46007-202
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 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
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CORN OIL (UNII: 8470G57WFM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SQUALANE (UNII: GW89575KF9)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PYRIDOXINE DIPALMITATE (UNII: HB49XCT029)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    MILLET (UNII: TJR6B3R47P)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46007-202-12 50 mL in 1 BOTTLE; 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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