Label: 100% MINERAL BODY MIST WITH GREEN TEA EXTRACT BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide liquid

  • 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, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Titanium Dioxide 10% Sunscreen

    Zinc Oxide 12% 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. If product is swallowed, get medical help or contact a poison Control Center right away

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    For external use only

    Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Do not use in the presence of a flame or spark or while smoking.

    Do not use on damaged or broken skin

    When using this product, keep away from face to avoid breathing it. Keep out of eyes

    Rinse with water to remove.

  • DOSAGE & ADMINISTRATION

    Directions

    SHAKE WELL to activate, if the mist is clear, keep shaking.

    • spray generously and spread evenly by hand 15 minutes before sun exposure
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face
    • reapply:
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit your time in the sun, especially from 10 a.m. – 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

    • Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aqua (Deionized Water), Ascorbyl Palmitate, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Capryl/Caprylyl Glucoside, Chamomilla Recutita (Chamomile) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    PLAY

    SPF 50

    100% Mineral Body Mist

    With Green Tea Extract

    Broad Spectrum Sunscreen SPF 50

    Water Resistant (80 minutes)

    6 fl. oz. / 177 ml.

    100 Mineral Body Mist SPF 50

  • INGREDIENTS AND APPEARANCE
    100% MINERAL BODY MIST WITH GREEN TEA EXTRACT BROAD SPECTRUM SPF 50 
    titanium dioxide, zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-212-01177 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2020
    Labeler - Supergoop, LLC (117061743)
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