Label: THINK KIDS MINERAL SPF 50- zinc oxide and titanium dioxide aerosol, spray

  • 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 June 1, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Titanium Dioxide 3.4%Sunscreen
    Zinc Oxide 15.7%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
  • Warnings

    For external use only

    Contents Under Pressure. Do not puncture or incinerate can. Do not store at temperatures above 120°F

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake well, apply liberally and evenly 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Children under 6 months of age: 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 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.
  • Inactive Ingredients

    Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Isononyl Isononanoate, Propanediol, Isocetyl Stearoyl Stearate, Methyl Dihydroabietate, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice, Musa Sapientum (Banana) Fruit Extract, Bentonite, Glycerin, Tocopherol, Citric Acid, Alumina, Sodium Gluconate, Bisabolol, Caprylhydroxamic Acid, Cellulose Gum, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Polyhydroxystearic Acid, Polyester-8, Silica, Sodium Stearoyl Glutamate, C18-21 Alkane.

  • Other Information

    • protect this product from excessive heat and direct sun
  • For Questions

    877.446.1616

  • SPL UNCLASSIFIED SECTION

    Dist.by: Think Operations, LLC
    Simi Valley, CA 93065 USA

  • PRINCIPAL DISPLAY PANEL - 177 ml Canister Label

    thinkkids

    reef friendly

    80
    min
    water
    resistant

    ALL SHEER MINERAL
    SUNSCREEN SPRAY

    50 SPF

    broad spectrum SPF 50
    dermatologist tested
    safe for sensitive skin
    no-fuss application
    air-powered spray

    6 fl oz • 177 ml

    Principal Display Panel - 177 ml Canister Label
  • INGREDIENTS AND APPEARANCE
    THINK KIDS MINERAL   SPF 50
    zinc oxide and titanium dioxide aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60781-4700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE157 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE34 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    METHYL DEHYDROABIETATE (UNII: 4P47O55S2W)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BANANA (UNII: 4AJZ4765R9)  
    BENTONITE (UNII: A3N5ZCN45C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    C18-C21 ALKANE (UNII: 33822S0M40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60781-4700-1177 mL in 1 CANISTER; Type 0: Not a Combination Product05/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35205/30/2023
    Labeler - thinkOperations,LLC (808883636)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555MANUFACTURE(60781-4700)
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!