Label: SPF30 SUNSCREEN- avobenzone, homosalate, octocrylene, ocitsalate spray

  • NDC Code(s): 70412-238-05, 70412-238-08, 70412-238-10, 70412-238-20, view more
    70412-238-30, 70412-238-60
  • Packager: Zhejiang Ayan Biotech Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Active Ingredients

    ​Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • WARNINGS:

    Spending time in the sun increases your risk of skin cnacer or early skin aging.  this product has been shown only to prevent sunburn skin cancer or early skin aging. this product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert:NOTNOT

    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

    Non-Water Resistant Product

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor
  • inactive ingredients.

    Water, Glycerin, Potassium Cetyl Phosphate, VP/Hexadecene Copolymer, Dimethicone, Phenoxyethanol, Acrylates/Beheneth-25 Methacrylate Copolymer, Caprylyl Glycol, Bisabolol, Fragrance, Triethanolamine, Disodium EDTA


  • Label

    8mL

    10mL

    20mL

    30mL

    60mL

  • INGREDIENTS AND APPEARANCE
    SPF30 SUNSCREEN 
    avobenzone, homosalate, octocrylene, ocitsalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    COCONUT (UNII: 3RT3536DHY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-238-088 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    2NDC:70412-238-2020 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    3NDC:70412-238-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    4NDC:70412-238-3030 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/01/2018
    5NDC:70412-238-1010 mL in 1 PACKAGE; Type 0: Not a Combination Product06/01/2018
    6NDC:70412-238-055 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2018
    Labeler - Zhejiang Ayan Biotech Co., Ltd. (544377996)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co., Ltd.544377996manufacture(70412-238)
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