Label: HEB FACE 50 CLEAR ZINC SUNSCREEN- octocrylene, zinc oxide lotion

  • 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 March 14, 2023

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  • Active ingredients

    Octocrylene 4.0%, Zinc Oxide 5.0%

  • 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 swallowed, get medical help or contact a 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

    Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Hexyl Laurate, Beeswax, Isohexadecane, Silica, Ethylhexylglycerin, Chlorphenesin, Fragrance, Triethoxycaprylylsilane, Dimethicone, Sodium Chloride, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Tocopherol.

  • Label

    HEB73255K1

    HEB73255E1

  • INGREDIENTS AND APPEARANCE
    HEB FACE 50 CLEAR ZINC SUNSCREEN 
    octocrylene, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-151-0928.4 g in 1 JAR; Type 0: Not a Combination Product01/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/07/2020
    Labeler - H.E.B. (007924756)