Label: SPF15- avobenzone, homosalate, octocrylene, octisalate lipstick

  • NDC Code(s): 70412-316-07, 70412-316-15, 70412-316-20
  • Packager: Zhejiang Ayan Biotech Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • Drug Facts

  • Active Ingredients

    Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2%


    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 reash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control right away.

  • Directions

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

    Mineral Oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

  • Other Information

    • Protect from excessive heat and direct sun.
  • Questions?

    Call AP Specialties 

    BATCH NO:

    Distributed by:

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    SPF15 
    avobenzone, homosalate, octocrylene, octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE55 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-316-154.5 g in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    2NDC:70412-316-205.67 g in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    3NDC:70412-316-072 g in 1 TUBE; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2018
    Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)
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