Label: SKIN SOOTHING MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUPERGOOP- octinoxate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 18, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Octinoxate 7.5% Sunscreen

    Zinc Oxide 10.1% Sunscreen

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

    · 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.

    Directions
    Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating
    -Children under 6 months: Ask a doctor
    -Reapply at least every 2 hours
    -Sun Protection Measures. Spending time in the sun increases your risk of skin
    cancer and early skin aging. To decrease this risk, regularly use a sunscreen
    with broad spectrum SPF of 15 or higher and other sun protection measures
    including:
    · limit time in the sun, especially from 10 a.m. - 2 p.m.
    · wear long-sleeve shirts, pants, hats, and sunglasses
    · Use a water resistant sunscreen if swimming or sweating

    Inactive ingredients Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Triethoxycaprylylsilane, Squalane, Xanthan Gum, Helianthus Annuus (sunflower) Seed Oil, Trisodium Ethylenediamine Dissucinate, Chlorphenesin, Ethylhexylglycerin, Oleth-3 Phosphate, Punica Granatum Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polysorbate 60, Citric Acid, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Fruit extract, Euterpe Oleracaea Fruit Extract, Methylisothiazolinone, Tocotrienols

  • PRINCIPAL DISPLAY PANEL

    Supergoop Skin Soothing Mineral Sunscreen

    with Olive Polyphenols

    Broad Spectrum SPF 40

    2.4 fl. oz./ 71 mL

    Box

    Primary

  • INGREDIENTS AND APPEARANCE
    SKIN SOOTHING MINERAL SUNSCREEN BROAD SPECTRUM SPF 40  SUPERGOOP
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    ACAI (UNII: 46AM2VJ0AW)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-129-021 in 1 BOX01/22/2014
    1NDC:75936-129-0171 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:75936-129-041 in 1 BOX01/22/2014
    2NDC:75936-129-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/22/2014
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company Inc620899877manufacture(75936-129)
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