Label: TIGER BABY BABY SUNSCREEN SPF-50- zinc oxide cream

  • NDC Code(s): 82247-278-00, 82247-278-01
  • Packager: BRICKELL BRANDS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 20.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn • Higher SPF gives more sunburn protection • 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:

    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 or irritation develops and lasts.

    Keep out of reach of children.

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

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    • Apply liberally 15-minutes before sun exposure and as needed • Children under 6 months of age: ask a doctor. • Reapply: 

    • After 80 minutes of swimming or 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. Sun Protection Measures.

  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia  Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Cetearyl Olivate, Citrullus Lunatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Gluconolactone, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Hydroxyethylcellulose, Olea Europaea (Olive) Oil, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sodium  Benzoate, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

  • Package Labeling:5ml

    LabelLabel2

  • Package Labeling:89ml

    Label3

  • INGREDIENTS AND APPEARANCE
    TIGER BABY BABY SUNSCREEN SPF-50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82247-278
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    WATERMELON (UNII: 231473QB6R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82247-278-005 mL in 1 PACKET; Type 0: Not a Combination Product02/21/2022
    2NDC:82247-278-011 in 1 BOX02/21/2022
    289 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/21/2022
    Labeler - BRICKELL BRANDS LLC (081141606)