Label: SPF30 SUNSCREEN AND ANTIBACTERIAL HAND SANITIZER- alcohol, avobenzone, homosalate, octocrylene, octisalate kit

  • NDC Code(s): 70412-119-05, 70412-238-05, 70412-817-05
  • 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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  • Drug Facts Antibacterial Hand Sanitizer

  • Active Ingredients

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    •Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use.

  • WARNINGS:

    For external use only. Flammable. Keep away from fire or flame.

    Do not apply around eyes,

    Do not use

    in ears & mouth.   

    When using this product

    avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor

    if redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry

  • Inactive ingredients.

    water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, carbomer, fragrance.

  • Other Information

    Store at room temperature 15°C to 30°C (59° F to 86° F)

  • Questions?

    Call

  • Drug Facts SPF30 Sunscreeen Spray

  • Active Ingredients

    Avobenzone 3%, Homosalate 10%,

    Octocrylene10%, Octisalate 5%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn

  • WARNINGS:

    Spending time in the sun increases your risk of skin cancer 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



    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •Limit time in the sun, especially from 10 a.m. to 2 p.m. •Wear long sleeve shirts, pants, hats and sunglasses. Sun Protection Measures.

  • Inactive ingredients.

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

  • Other information

    •Protect this product from excessive heat and direct sun

  • Questions?

    Call

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SPF30 SUNSCREEN AND ANTIBACTERIAL HAND SANITIZER 
    alcohol, avobenzone, homosalate, octocrylene, octisalate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-817
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-817-051 in 1 KIT09/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 5 mL
    Part 21 TUBE 5 mL
    Part 1 of 2
    ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Item Code (Source)NDC:70412-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-119-051 in 1 BOX
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/01/2018
    Part 2 of 2
    SPF30 SUNSCREEN 
    avobenzone, homosalate, octocrylene, ocitsalate spray
    Product Information
    Item 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 PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-238-055 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2018
    Labeler - Zhejiang Ayan Biotech Co., Ltd. (544377996)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co., Ltd.544377996manufacture(70412-817, 70412-119, 70412-238)
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