Label: ALOE UP SPORT NATURAL BALM SPF-15- avobenzone, octinoxate, octisalate, octocrylene stick

  • NDC Code(s): 61477-219-11
  • Packager: Aloe Care International, LLC
  • 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 February 18, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Avobenzone (2%)

    Octinoxate (6.5%)

    Octisalate (5%)

    Octocrylene (1.5%)

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  • PURPOSE

    SUNSCREEN

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  • USES

    • HELPS PREVENT SUNBURN.
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  • 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.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • WARNINGS

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin

    Stop use and ask a doctor if rash occurs

    When using this product keep out of eyes. Rinse with water to remove.

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  • INACTIVE INGREDIENTS

    Aloe Vera Leaf Extract, Avocado Oil, Beeswax, BHT, Canola Oil, Caprylic/Capric Triglyceride, Castor Seed Oil, Coconut Oil,
    Hydrogenated Vegetable Oil, Lanolin Oil, Mango Butter, Sunflower Seed Oil, Tocopherol, Tocopheryl Acetate.

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  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun
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  • QUESTIONS OR COMMENTS?

    Toll Free 800-950-2563 www.aloeup.com

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  • INGREDIENTS AND APPEARANCE
    ALOE UP SPORT NATURAL BALM  SPF-15
    avobenzone, octinoxate, octisalate, octocrylene stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61477-219
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61477-219-11 4.25 g in 1 TUBE; Type 0: Not a Combination Product 02/24/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 02/24/2014
    Labeler - Aloe Care International, LLC (938242187)
    Registrant - Aloe Care International, LLC (938242187)
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