FLAWLESS FINISH FOUNDATION by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

FLAWLESS FINISH FOUNDATION by

Drug Labeling and Warnings

FLAWLESS FINISH FOUNDATION by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLAWLESS FINISH FOUNDATION SPF 15 SUNSCREEN- octisalate, titanium dioxide liquid 
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 Ingredients:

​OCTISALATE (2%)

TITANIUM DIOXIDE (5.5%)

Purpose:

SUNSCREEN

Uses:

HELPS PREVENT SUNBURN

Warnings:

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 ONLY TO 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 GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE
• CHILDREN UNDER 6 MONTHS OF AGE; ASK A DOCTOR.
• 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 SUN 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 SHIRT, 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 SUNLIGHT.
• STORE AT ROOM TEMPERATURE 15°C - 30°C (59°F - 86°F)

Inactive Ingredients:

WATER (AQUA), GLYCERIN, ISODODECANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CYCLOMETHICONE, TRIDECYLTRIMELLITATE, PROPYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, CYCLOPENTASILOXANE, PEG/PPG-15/15 DIMETHICONE, SORBITAN SESQUIOLEATE, SILICA, POLYMETHYL METHACRYLATE, TALC, SYNTHETIC BEESWAX, MAGNESIUM SULFATE, DISTEARDIMONIUM HECTORITE, SILICA DIMETHYL SILYLATE, BORON NITRIDE, MAGNESIUM STEARATE, PHENOXYETHANOL, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCRBOMATE, FRAGRANCE (PARFUM)  MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

QUESTIONS OR COMMENTS

1-855-353-7320

FLAWLESS FINISH FOUNDATION  SPF 15 SUNSCREEN
octisalate, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5   in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
TALC (UNII: 7SEV7J4R1U)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-106-51	1 in 1 BOX	10/10/2013	12/31/2017
1	NDC: 76354-106-11	23 g in 1 CONTAINER; 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: 4/2014

Document Id: b3fdb218-bd6e-4d2f-8b7a-2f4de3f2a77f

34390-5

Set id: 72d88954-bd9c-4470-987b-6257575aa9b9

Version: 2

Effective Time: 20140408