ELF BB by J. A. Cosmetics U.S. INC

ELF BB by

Drug Labeling and Warnings

ELF BB by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF BB SPF-20- oxybenzone, octisalate, and octinoxate cream 
J. A. Cosmetics U.S. INC

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.

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Active Ingredient:

OXIBENZONE: 4%

OCTISALATE: 5%

OCTINOXATE: 7.5%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

Warning:

For external use only

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 to only help prevent sunburn, not skin cancer or skin aging.

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.

Directions:

• Apply generally 15 minutes before sun exposure.
• Children under six months of age; ask a doctor.
• Reapply at least every two hours
• Use a water resistant sunscreen if swimming or sweating

Other Information

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.
• STORE AT ROOM TEMPERATURE 15°C-30°C (59°F-86°F)

Inactive Ingredient:

WATER (AQUA), GLYCERIN, PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, TITANIUM DIOXIDE, CETYL PEG/PPG-10/1 DIMETHICONE, CYCLOHEXASILOXANE, SORBITAN OLIVATE, POLYMETHYL METHACRYLATE, SODIUM CHLORIDE, QUATERNIUM-18 BENTONITE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, ZINC STEARATE, TALC, VP/HEXADECENE COPOLYMER, BISABOLOL, TOCOPHERYL ACETATE (VE), SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, MICA, SILICA, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, METHYLISOTHIAZOLINONE

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499)

ELF BB  SPF-20
oxybenzone, octisalate, and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5   in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC STEARATE (UNII: H92E6QA4FV)
TALC (UNII: 7SEV7J4R1U)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
MICA (UNII: V8A1AW0880)
SILICON (UNII: Z4152N8IUI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-101-51	1 in 1 BOX	10/10/2013	12/31/2017
1	NDC: 76354-101-11	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 final	part352	10/10/2013	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 6/2014

Document Id: f7a9349b-92f7-4b4f-b433-82afd04ae592

34390-5

Set id: 2450ab67-6898-4231-816a-0e6bf532fcf3

Version: 4

Effective Time: 20140610

 

J. A. Cosmetics U.S. INC