AC CARE BEES SHIELD BB BROAD SPECTRUM SPF 35- octinoxate, titanium dioxide, zinc oxide cream

ac care Bees Shield BB by

Drug Labeling and Warnings

ac care Bees Shield BB by is a Otc medication manufactured, distributed, or labeled by DongSung Pharm Co., Ltd., Dong Sung World Wide USA, Inc., Omar Sharif Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

a.c.care BEE'S Shield B.B. Cream

Broad Spectrum SPF 35

Optimized fusion of Bee Venom, Honey and Royal Jelly Extracts, which are from Honeybees, a.c.care Bee's Shield B.B. Cream naturally covers blemishes, making your skin flawless and glow like honey-glossed. Natural ingredients derived from power and wisdom of honeybee help your skin to relax from stress, giving a perfect match for sensitive skin!

'Skin-Shielding' multi-functional B.B. Cream for clear skin and a flawless complexion

ACTIVE INGREDIENT

Active Ingredients

Octinoxate 7%

Titanium Dioxide 4.41%

Zinc Oxide 1.96%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

Not only will it help prevent sunburn, it also reduces the risk of skin cancer and early skin aging if used as directed with other sun protection measures. (SPF value of 15 or higher)

WARNINGS

Warnings

For external use only. Do not use on damaged or broken skin. Discontinue use if signs of irritation or rash appear. Avoid contact with eyes. Wash off immediately with cold water if product comes in contact with eyes. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. 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. and wear long-sleeved shirts, pants, hats and sunglasses. For use on skin only. Allergy Alert: Contains Bee Venom. Customers with known bee allergies should not this product as bee venom may induce allergic response(s).

INSTRUCTIONS FOR USE

Directions

At the end of basic skin care regimen, apply liberally on face to cover the entire facial area and lightly go over parts where extra cover-up is needed with detailed perfection. Apply 15 minutes before sun exposure. For added protection, reapply at least every 2 hours, after swimming, towel drying or extended sun exposure. Use a water resistant sunscreen if swimming or sweating.

Children under 6 months: Ask a doctor.

OTHER SAFETY INFORMATION

Other Information

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Cyclopentasiloxane, Dimethicone Copolyol, Butylenes Glycol, Talc, Cyclohexasiloxane, Cethyl Ethylhexanoate, Quaternium-18 Bentonite, Dimethicone, Glycerin, Mineral Oil, Arbutin, PEG-10 Glyceryl Triisostearate, Magnesium Sulfate, Magnesium Stearate, Iron Oxides (CI 77492, CI 77491, CI 77499), Methylparaben, Ammonium Glycyrrhizate, Tocopheryl Acetate, Panthenol, Propylparaben, Dimethiconol Stearate, Adenosine, Allantoin, Aluminum Dimyristate, Honey Extract, Hydrolyzed Silk, Sodium Hyaluronate, Portulaca Oleracea Extract, Camellia Japonica Flower Extract, Royal Jelly Extract, Bee Venom

Package Image

INGREDIENTS AND APPEARANCE

AC CARE BEES SHIELD BB  BROAD SPECTRUM SPF 35
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42361-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	44.1 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.6 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
APIS MELLIFERA VENOM (UNII: 76013O881M)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
BENTOQUATAM (UNII: 7F465U79Q1)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
ARBUTIN (UNII: C5INA23HXF)
PEG-10 GLYCERYL TRIISOSTEARATE (UNII: 8U46MJI8HO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ)
CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)
ROYAL JELLY (UNII: L497I37F0C)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALLANTOIN (UNII: 344S277G0Z)
HONEY (UNII: Y9H1V576FH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
TALC (UNII: 7SEV7J4R1U)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42361-151-01	1 in 1 CARTON	04/01/2016
1		50 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	04/01/2016

Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661)

Registrant - Dong Sung World Wide USA, Inc. (784969219)

Establishment
Name	Address	ID/FEI	Business Operations
Dong Sung Bio Pharm. Co., Ltd		687811661	label(42361-151)

Establishment
Name	Address	ID/FEI	Business Operations
Omar Sharif Cosmetic Co., Ltd.		689316318	manufacture(42361-151)