Label: BB OSKIN BROAD SPECTRUM SPF-30- titanium dioxide, octocrylene, zinc oxide cream

  • NDC Code(s): 83276-390-00, 83276-390-01
  • Packager: O'Skin Studio NY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredients

    Titanium dioxide 7.00%

    Octocrylene 5.00%

    Zinc Oxide 6.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • higher SPF gives more sunburn protection
    • if used as directed with other sun protection meassures (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 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.

    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 at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures. 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, expecially from 10 a.m.-2 p.m.
    • Wear long-sleevd shirts, pants, hats, and sunglasses.
  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients:

    Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea Butter), C12-15 Alkyl Benzoate, Caffeine, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Cocos Nucifera (Coconut) Oil, Coffea Arabica Seed Extract, Cymbopogon Flexuosus (Lemongrass) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower Oil), Hyaluronic Acid, Iron Oxides (Black, Red, White, Yellow), Lecithin, Magnesium Aluminum Silicate, Mauritia Flexuosa (Buriti) Oil, Niacinamide, Octyldodecyl Neopentanoate, Ocimum Basilicum (Basil) Extract, Sodium Polyacrylate, Sorbitan Stearate, Ubiquinone (CoQ10), Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, Zingiber Officinalis (Ginger) Extract, ZIngiber Officinalis (Ginger) Oil,

  • Questions or comments?

    (347-335-5540) Visit us: www.oskinstudionyc.com

  • Package Labeling:5ml

    Outer Package

  • Package Labeling:50.2ml

    Bottle

  • INGREDIENTS AND APPEARANCE
    BB OSKIN BROAD SPECTRUM SPF-30 
    titanium dioxide, octocrylene, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83276-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DODECANE (UNII: 11A386X1QH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BASIL (UNII: 2U0KZP0FDW)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN (UNII: 0N8672707O)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83276-390-005 mL in 1 PACKET; Type 0: Not a Combination Product02/27/2023
    2NDC:83276-390-0150.2 mL in 1 BOTTLE; Type 0: Not a Combination Product02/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/27/2023
    Labeler - O'Skin Studio NY (014068844)
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