Label: BROAD SPECTRUM SPF50 WATER RESISTANT (80 MINUTES) MINERAL SUNSCREEN UVA UVB PROTECTION STICK FOR KIDS- zinc oxide stick

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

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredients

    Zinc Oxide 20.0%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn.
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an 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 or sweating. • immediately after towel drying • at least every 2 hours. • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly measures including: • limit time in the sun, especially from 10 a.m.-2 p.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

    Candelilla Wax, Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Myristyl Myristate, C18-20 Alkane, Butyrospermum Parkii (Shea) Butter, C13-14 Alkane, Tridecyl Salicylate, Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Wax, Tocopheryl Acetate, Fragrance (Parfum), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Sorbitan Oleate, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane.

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF50 WATER RESISTANT (80 MINUTES) MINERAL SUNSCREEN UVA UVB PROTECTION STICK FOR KIDS 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANDELILLA WAX (UNII: WL0328HX19)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53675-205-0030 mL in 1 CONTAINER; Type 0: Not a Combination Product03/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/08/2022
    Labeler - Aruba Aloe Balm NV (855442273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aruba Aloe Balm NV855442273manufacture(53675-205)
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