Label: MINERAL SUNSCREEN STICK SPF 50 SUPERGOOP- zinc oxide stick

  • 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 11, 2021

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  • ACTIVE INGREDIENT

    ​Active Ingredients            Purpose

    ​Zinc Oxide 17% ............... 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

    ​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 body at least 15 minutes prior to sun exposure
    • Reapply after 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Chlidren under 6 months: Ask a doctor

    ​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 a Broad Spectrum SPF value of 15 or higher and take other sun protection measures including:

    • Limit time in the sun, especially from 10a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Beeswax, Bisabolol,

    Butyrospermum Parkii (Shea) Butter, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Jojoba Esters, Linum Usitatissimum (Linseed) Seed Oil, Octyldodecyl Oleate, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Salvia Hispanica (Chia) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cocao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract

  • PRINCIPAL DISPLAY PANEL

    Supergoop

    SPF  50

    Water resistant (80 minutes)

    100% Mineral Sunscreen Stick

    With Avocado Oil

    Broad Spectrum SPF 50

    Front

    Back

  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN STICK SPF 50   SUPERGOOP
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-511-0118.9 g in 1 TUBE; Type 0: Not a Combination Product08/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/14/2017
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)