Label: HEB SPF 50 HYDRATE 50 SUNSCREEN WITH HYALURONIC ACID AND COLLAGEN CONTINUOUS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

  • 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

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

  • Active Ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protetion measures (see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

  • FLAMMABLE:

    • do not use near heat, flame or while smoking
    • avoid long term stoage above 104°F (40°C)
  • Do not use

    • on damaged or broken skin.

  • When using this product

    • keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

  • 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
    • hold can 4-6 inches away from body, spray evenly to ensure complete coverage
    • do not spray into face. Spray into hand and apply to face.
    • use in well ventilated, but not windy areas
    • 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.

    • wearl 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

    SD ALCOHOL 40-B, BUTYLOCTYL SALICYLATE, FRAGRANCE, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ALOE BARBADENSIS LEAF JUICE, BUTYLENE GLYCOL, SACCHAROMYCES/ PODOPHYLLUM PELTATUM FERMENT FILTRATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, PANTHENOL, PERSEA GRATISSIMA (AVOCADO) OIL, VITIS VINIFERA (GRAPE) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, STEAROXYTRIMETHYLSILANE, TOCOPHEROL, HYDROLYZED COLLAGEN, HYDROLYZED HYALURONIC ACID.

  • Label

    HEB73414D1

  • INGREDIENTS AND APPEARANCE
    HEB SPF 50 HYDRATE 50 SUNSCREEN WITH HYALURONIC ACID AND COLLAGEN CONTINUOUS SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)  
    PODOPHYLLUM (UNII: 2S713A4VP3)  
    WATER (UNII: 059QF0KO0R)  
    CARROT (UNII: L56Z1JK48B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-143-37156 g in 1 CAN; Type 0: Not a Combination Product01/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/27/2022
    Labeler - H.E.B (007924756)