Label: SPF 15 LIP AND SPF 30 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate kit

  • 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 May 24, 2018

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  • Drug Facts

  • Active Ingredients

    Homosalate 2%
    Avobenzone 8%
    Octocrylene 5.5%
    Octisalate 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 rash occurs.

    Keep out of reach of children.

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

  • Directions

    • 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

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

  • Other Information

    • Protect from excessive heat and direct sun.

  • Questions?

    Call AP Specialties

  • Drug Facts

  • Active Ingredients

    Homosalate 2%
    Avobenzone 8%
    Octocrylene 5.5%
    Octisalate 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 rash occurs.

    Keep out of reach of children.

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

  • Directions

    • 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

    Mineral Oil, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Hydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Tridecyl Trimellitate, Ozokerite, Synthetic Wax, Dextrin Palmitate, BHT, Tocopheryl Acetate, Fragrance.

  • Other Information

    • Protect from excessive heat and direct sun.

  • Questions?

    Call AP Specialties

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    SPF 15 LIP AND SPF 30 SUNSCREEN 
    avobenzone, homosalate, octocrylene, octisalate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-816
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-816-101 in 1 KIT06/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 4.5 g
    Part 21 TUBE 2 g
    Part 1 of 2
    SPF15 
    avobenzone, homosalate, octocrylene, octisalate lipstick
    Product Information
    Item 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)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    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 Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2018
    Part 2 of 2
    SPF30 SUNSCREEN 
    avobenzone, homosalate, octocrylene, octisalate stick
    Product Information
    Item Code (Source)NDC:70412-211
    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
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    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:70412-211-152 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2018
    Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)
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