Label: BB SHADE 30 RADIANCE SPF15- zinc oxide, titanium dioxide cream

  • 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 December 21, 2017

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  • Active Ingredients

    8.7% Zinc Oxide

    4.6% Titanium Dioxide

  • Purpose

    Sunscreen

  • Uses

    evens skin tone while protecting against sun's UVA + UVB rays

  • 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 prevent sunburn, not skin cancer or early skin aging
    • 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 product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    BB cream is a moisturizing skincare/makeup hybrid that is your primer, SPF, soothing treatment, concealer and foundation in one. After your normal skin care regimen, apply and blend well.

  • Other Ingredients

    Aloe Barbadensis (Aloe Juice) Leaf Extract, Centaurea Cyanus Flower Water/ Centaurea Cyanus (Cornflower) Flower Water, (Non-Nano) Zinc Oxide, Caprylic/ Capric Triglceride (Derived from Coconut Oil), Sorbitan Sesquioleate (Derived from Sugar) Titanium Dioxide, Vegetable Glycerin, Stearic Acid (Derived from Coconut), Hydrated SIlica, Leuconostoc/ Radish Root Ferment Filtrate, Magnesium Stearate (Derived from Salt), Mica (MIneral), Sodium Phytate (Sodium Salt from Plant Seeds) Xanthan Gum (Non-GMO), Simmondsia Chinensis Seed Oil/ Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii Butter/ Butyrospermum Parkii (Shea Butter), Vaccinium Myrtilus Seed Oil/ Vaccinium Myrtilus (Bilberry) Seed Oil, Lavandula Angustifolia Oil/ Lavandul Angustifolia (Lavender) Oil, Rosmarinus Officinalis Leaf Extract/ Rosmarinus Officinalis (Rosemary) Leaf Extract, Prinus Avium Seed Oil/ Prunus Avium (Sweet Cherry) Seed Oil, Prunus Cerasus Seed Oil/ Prunus Cerasus (Bitter Cherry) Seed Oil, Punica Granatum (Pomegranate) Fruit Extract, Helianthus Annuus Seed Oil/ Helianthus Annuus (Sunflower) Seed Oil, Rubus Idaeus Seed Oil/ Rubus Idaeus (Rasberry) Seed Oil, Tocopherol (Derived from Rice Bran-Non GMO), Benzyl Alcohol (Plant Derived), Dehydroacetic Acid, Potassium Sorbate (Salt of Sorbic Acid), Sorbic Acid (Derived from Sugar) May contain: Titanium Dioxide, Iron Oxides

  • Other Information

    protect this product from excessive heat and direct sun

  • Questions or Comments?

    call 1.415.814.9788 or visit www.100PercentPure.com

  • PRINCIPAL DISPLAY PANEL

    BB Shade 30 Radiance SPF15 Cream

    1 fl oz / 30 ml

    52667-009-30

    Label 1Label 2

  • INGREDIENTS AND APPEARANCE
    BB SHADE  30 RADIANCE SPF15
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52667-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE46 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION87 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICA (UNII: V8A1AW0880)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ROSEMARY (UNII: IJ67X351P9)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SORBIC ACID (UNII: X045WJ989B)  
    JOJOBA OIL (UNII: 724GKU717M)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BILBERRY SEED OIL (UNII: KK0KHX972K)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    SOUR CHERRY SEED OIL (UNII: JLQ4876E96)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52667-009-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/21/2017
    Labeler - Purity Cosmetics (055795259)
    Establishment
    NameAddressID/FEIBusiness Operations
    B. KOLORMAKEUP & SKINCARE SPA439270534manufacture(52667-009)
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