BB CARE ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 PLUS- titanium dioxide, zinc oxide cream

BB Care Ultra Light Sunscreen Broad Spectrum SPF 50 Plus by

Drug Labeling and Warnings

BB Care Ultra Light Sunscreen Broad Spectrum SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by Beauty Be Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium dioxide 7.82%

Zinc Oxide 0.96%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• 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

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 liberally 15 minutes before sun exposure
• 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 this risk, regularly use a sunscreen with a broad spectrum SPF value 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
• 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

Cyclomethicone, Dimethicone Crosspolymer, Cyclopentasiloxane, PEG-10 Dimethicone, Alumina, Methicone, Water, Simethicone, Phenyl Trimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disteardimonium Hectorite, Acrylates/Dimethicone Copolymer,  Tocopheryl Acetate, Hexyldecanol, Crab Apple (Pyrus malus) Seed Extract, Caprylic/Capric Triglyceride, Diacetyl Boldine, Strawberry (Fragaria vesca) Fruit Extract, Blueberry (Vaccinium angustifolium) Fruit Extract, Blackberry (Rubus corchorifolius) Fruit Extract, Raspberry (Rubus
occidentalis) Fruit Extract, Cranberry (Vaccinium macrocarpon) Fruit Extract, Melanin, Pentylene Glycol, Ethylhexylglycerine, Silica, Nylon-12, Polymethylsilsesquioxane, Jojoba (Simmondsia chinensis) Seed Oil, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Talc, Iron Oxides (CI 77491), Iron Oxides (CI 77492)

Package Labeling:

INGREDIENTS AND APPEARANCE

BB CARE ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 PLUS 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71388-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78.2 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHICONE (20 CST) (UNII: 6777U11MKT)
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYLDECANOL (UNII: 151Z7P1317)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIACETYL BOLDINE (UNII: 37727Z7M0I)
ALPINE STRAWBERRY (UNII: CG6IX3GCMU)
VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)
BLACKBERRY (UNII: 8A6OMU3I8L)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
JOJOBA OIL (UNII: 724GKU717M)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71388-001-00	1 in 1 BOX	04/14/2017
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/14/2017

Labeler - Beauty Be Co., Ltd (662340075)