Label: KIDS BROAD SPECTRUM SPF 35- zinc oxide cream

  • 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 January 8, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 18.9%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Provide high protection against sunburn.
    • Provide broad spectrum (UVA and UVB) protection.
    • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    Warnings: For external use only.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop and ask a doctor if rash or irritation occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours.
    • Children under 6 months: Ask a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Phenoxyethanol, Xanthan Gum, Carageenan, Helionori, Punica Granatum (Pomegranate) Extract, Plantago Lanceolate (Plantain) Leaf Extract, Ascorbyl Palmitate (Vitamin-C), Ethylhexylglycerin.

  • OTHER SAFETY INFORMATION

    High sun protection product.

  • QUESTIONS

    Questions? Call toll free 1-800-798-7970

  • PRINCIPAL DISPLAY PANEL

    Sun Research LLC

    Santa Cruz, CA

    www.burnoutsun.com

    IMGKBSSPF35

  • INGREDIENTS AND APPEARANCE
    KIDS BROAD SPECTRUM SPF 35 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE189 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4114-196 g in 1 TUBE; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/04/2017
    Labeler - Allure Labs Inc. (926831603)
    Registrant - Allure Lab Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4114)
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