BB SHADE 10 LUMINOUS SPF15- zinc oxide, titanium dioxide cream

BB Shade by

Drug Labeling and Warnings

BB Shade by is a Otc medication manufactured, distributed, or labeled by Purity Cosmetics, B. KOLORMAKEUP & SKINCARE SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 10 Luminous SPF15 Cream
1 fl oz/ 30 ml

52667-007-30

INGREDIENTS AND APPEARANCE

BB SHADE  10 LUMINOUS SPF15
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52667-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	46 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	87 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52667-007-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/20/2017

Labeler - Purity Cosmetics (055795259)

Establishment
Name	Address	ID/FEI	Business Operations
B. KOLORMAKEUP & SKINCARE SPA		439270534	manufacture(52667-007)