Label: SUNSCREEN- octinoxate, octisalate, zinc oxide gel

  • 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 December 9, 2022

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  • claims

    H-E-B

    Solutions

    sunscreen

    • With Aloe and Vitamin E
    • Water Resistant (80 minutes)
    • Oil Free & Wont Clog Pores
    • Clear Zinc Sunscreen for Race, Nose or Ears

  • Active ingredient

    Octinoxate 7.5%

    Octisalate 5%

    Zinc oxide 10%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), mdecreases 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 80 minures 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 derease this risk,  reqularly 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
    • children under 6 months of age: Ask a doctor
  • other information

    • protect the product from excessive heat and direct sun
  • inactive ingredients

    water, butyloctyl salicylate, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, propanediol, triacontanyl PVP, cetearyl alcohol, PEG-100 stearate, cetearyl glucoside, glyceryl behenate, dimethicone, glycerin, PEG-150/decyl alcohol/SMDI copolymer, Aloe barbadensis leaf juice, allantoin, panthenol, tocopheryl acetate, triethoxycaprylylsilane, fragrance, phenoxyethanol, methylisothiazolinone, tetrasodium EDTA

  • Questions?

    1-800-527-7731

  • Disclaimer

    May stain or damage some fabrics or surfaces

    MADE WITH PRIDE AND CARE FOR H-E-B

    SAN ANTONIO, TN 78204

    MADE IN USA WITH U.S AND FOREIGN PARTS

    100% GUARANTEE

    Promise

    If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.  You have our word on it

  • Principal panel display

    H-E-B

    Solutions

    Sunscreen

    CLEAR

    ZINC

    WITH OCTINOXATE & OCTISALATE

    SUNSCREEN

    BROAD SPECTRUM SPF 50

    SPF 50

    FOR FACE, NOSE OR EARS

    • With Aloe and Vitamin E
    • Water Resistant (80 minutes
    • Oil free & Wont Clog Pores

    NET WT.

    1 OZ (28.3 g)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    octinoxate, octisalate, zinc oxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-726
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE562 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE250 g  in 1 g
    Zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1000 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%) (UNII: VP5LS3541F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-726-1028.3 g in 1 PACKAGE; Type 0: Not a Combination Product06/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/06/2017
    Labeler - HEB (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-726)
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