LIFECELL BROAD SPECTRUM SPF 30 BB CREAM- octinoxate and zinc oxide cream

Lifecell by

Drug Labeling and Warnings

Lifecell by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DARK

Uses

LifeCell BB cream provides all-day hydration, SPF 30 protection and enough coverage to reduce the appearance of imperfections.

Directions

Apply liberally 20 minutes before sun exposure.

Active Ingredients

Octinoxate 3%

Zinc Oxide 3%

PURPOSE

Sunscreen

OTHER SAFETY INFORMATION

Hypoallergenic

Dermatologist Tested

Lifecell BB Cream Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

LIFECELL  BROAD SPECTRUM SPF 30 BB CREAM
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.01 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	29.01 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALMOND OIL (UNII: 66YXD4DKO9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BENTONITE (UNII: A3N5ZCN45C)
CARAMEL (UNII: T9D99G2B1R)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OCTYL STEARATE (UNII: 772Y4UFC8B)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0191-3	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2013

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0191) , manufacture(58443-0191) , label(58443-0191)