Label: EVERYDAY SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate 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 January 5, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients      Purpose

    Avobenzone 3%         Sunscreen                   

    Homosalate 10%       Sunscreen

    Octinoxate 7.5%        Sunscreen

    Octisalate 5%            Sunscreen

  • PURPOSE

    Uses Helps Prevent Sunburn

    If used as directed with other sun protection measures (see Directions), decreases the risk of Skin cancer and early skin aging caused by the sun

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    For External use only

    Do not use on damaged or broken skin

    When using this product, Keep out of eyes. Rinse with water to remove

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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply Liberally to face and and body at least 15 minutes prior to sun exposure. water resistant

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Isododecane, Polyester-8, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Potassium Cetyl Phosphate, Phenoxyethanol, Cetearyl alcohol, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Diethylhexyl, Syringylidenemalonate, Acrylates Copolymer, Cetyl Alcohol, Beheneyl Alcohol, Ethylhexylglycerin, Glyceryl Stearate, Chlorpehensin, Xanthan Gum, Caprylyl Glycol, Palmitic Acid, Stearic Acid, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Lauryl Alcohol, Myristyl Alcohol, Aniba Rosaeodora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Limonene, Allantoin, Disodium EDTA, Thermus Thermophillus Ferment, Lecithin, Pentylene Glycol, Panthenol, Sodium Hydroxide, BHT, Cassia Alata Leaf Extract, Maltodextrin, Gernaniol, Citral, 1,2-Hexandiol, Beta Glucan, Citric Acid, Sodium Benzoate, Tocopheryl, Potassium Sorbate

  • PRINCIPAL DISPLAY PANEL

    Supergoop Play

    SPF 50

    Water Resistant (80 minutes)

    Everyday Sunscreen with cellular response technology

    Broad Spectrum SPF 50

    Oil-free, face & body lotion protects from sun's rays, defending skin from photoaging

    and dehydration

    2.4 Fl. Oz. / 71 ml

    Secondary Art

    Primary Art

  • INGREDIENTS AND APPEARANCE
    EVERYDAY SUNSCREEN SPF 50  SUPERGOOP
    avobenzone, homosalate, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BEHENIC ACID (UNII: H390488X0A)  
    CETYL BEHENATE (UNII: WFM51TRO3E)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    POGOSTEMON CABLIN TOP (UNII: 2I2A73IYL7)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GERANIOL (UNII: L837108USY)  
    CITRAL (UNII: T7EU0O9VPP)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-135-021 in 1 CARTON01/20/2015
    1NDC:75936-135-0171 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:75936-135-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
    3NDC:75936-135-04222 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
    4NDC:75936-135-05532 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
    5NDC:75936-135-063 mL in 1 PACKET; Type 0: Not a Combination Product01/20/2015
    6NDC:75936-135-0710 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/20/2015
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company, Inc.620899877manufacture(75936-135)
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