Label: HEB BROAD SPECTRUM SPF 30 MANGO SCENTED SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene 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 July 9, 2021

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

  • Active ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn

  • 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

    C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, flavor, aloe barbadensis leaf extract, mineral oil, ascorbyl palmitate, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol.

  • PRINCIPAL DISPLAY PANEL

    HEB20864E

    HEB20864K

  • INGREDIENTS AND APPEARANCE
    HEB BROAD SPECTRUM SPF 30 MANGO SCENTED SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-930
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-930-892 in 1 CARTON04/01/2019
    1NDC:37808-930-580.15 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2019
    Labeler - H.E.B (007924756)