Label: SUNSCREEN SPF 50 PLUS BROAD SPECTRUM UVA UVB PROTECTION- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredients

    Avobenzone 3%

    Homosalate 5%

    Octinoxate 7.5%

    Octisalate 5%

    Octocrylene 10% 

    Oxybenzone 6%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn

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

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 15 minutes before sun exposure
    • reapply
    • after 80 minutes of swimming of sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 andd other sun protection measures including: Sun Protection Measures. 
    • limit time in the sun, especially from 10 a.m.-2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor
  • Other Information

    • protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    aloe barbadensis leaf juice (aloe vera gel), caprylyl glycol, chlorophenesin, cocos nucifera oil (coconut oil), dicaprylyl carbonate, dimethicone, fragrance (parfum), pentaerythrityl glutamate, tocopheryl acetate (vitamin E acetate), vp/eicosene copolymer, water (aqua/eau).

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 50 PLUS BROAD SPECTRUM UVA UVB PROTECTION 
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-165
    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) HOMOSALATE50 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53675-165-0059 mL in 1 TUBE; Type 0: Not a Combination Product06/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/10/2017
    Labeler - Aruba Aloe Balm NV (855442273)
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