Label: 100% MINERAL BROAD SPECTRUM SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 75936-362-01, 75936-362-02
  • Packager: Supergoop LLC
  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    TItanium Dioxide 2.3% Sunscreen

    Zinc Oxide 17.9% Sunscreen

  • PURPOSE

    Uses

    Helps prevent sunburn

    If used as directed with other sun protection measures (see Directions), decreases the risk of skincancer 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 product is swallowed, get medical help or contact a Poison Control right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • apply generously and evenly 15 minutes before sun exposure

    reapply

    • after80 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 sub and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.- 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Vulgare Kernel Oil, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, C13-14 Alkane, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucosde, Diheptyl Succinate, Erythritol, Ethyl Ferulate, Glycerin, Haematococcus Pluvialis Extract, Jojoba Esters, Lauryl Laurate, Methyl dihydroabietate, Microcrystalline Cellulose, Neopentyl Glycol Diheptanoate, Polyester-7, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sea Water, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    PLAY

    SPF 50

    100% Mineral Lotion

    With Green Algae

    Broad Spectrum Sunscreen SPF 50 PA++++

    Water resistant (80 minutes)

    3.4 fl. oz. / 100 ml.

    Play 100% mineral lotion tube

  • INGREDIENTS AND APPEARANCE
    100% MINERAL BROAD SPECTRUM SUNSCREEN SPF 50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-362
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POLYESTER-7 (UNII: 0841698D2F)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ERYTHRITOL (UNII: RA96B954X6)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-362-0130 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2022
    2NDC:75936-362-02100 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/04/2022
    Labeler - Supergoop LLC (117061743)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!