Label: EQUATE SUNSCREEN MINERAL BASED KIDS BROAD SPECTRUM SPF 50- homosalate , octocrylene, zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 30, 2022

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  • Active ingredients

    Homosalate 5.0%,

    Octocrylene 10.0%,

    Zinc Oxide 15.0%

  • Purpose

    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

  • 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 Poison Control Center right away.

  • Directions

    • apply liberally 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses

  • Other information

    • protect the product in this container from excessive heat and direct sun

    • may stain or damage some fabrics, materials or surfaces

  • Inactive ingredients

    caprylic/capric triglyceride, ozokerite, theobroma cacao (cocoa) seed butter, tridecyl salicylate, lauryl laurate bis-PEG-12 dimethicone beeswax, C12-15 alkyl benzoate, synthetic beeswax

  • Label

    EQ10967E2F2

  • INGREDIENTS AND APPEARANCE
    EQUATE SUNSCREEN MINERAL BASED KIDS BROAD SPECTRUM SPF 50 
    homosalate , octocrylene, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-962
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-962-2842 g in 1 BOTTLE; Type 0: Not a Combination Product03/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/26/2019
    Labeler - Wal-Mart Stores Inc (051957769)
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