SPF-20 FACE PRIMER by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

SPF-20 FACE PRIMER by

Drug Labeling and Warnings

SPF-20 FACE PRIMER 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]

SPF-20 FACE PRIMER- octinoxate, oxybenzone, octisalate 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:

OCTINOXATE 7%

OXYBENZONE 5%

OCTISALATE 5%

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.

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 ONLY TO HELP PREVENT SUNBURN, NOT SKIN CANCER OR SKIN AGING.

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.

Directions:

APPLY TO CLEAR SKIN PRIOR TO MAKEUP APPLICATION. USE A SMALL AMOUNT AND BLEND EVENLY ALL OVER THE FACE FOR A SMOOTH AND FLAWLESS BASE. FOR SUNSCREEN USE:

• 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 SUN CNCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURS 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 DOCTOR.

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

Inactive Ingredient:

DIMETHICONE, DIMETHICONE CROSSPOLYMER, ETHYLHEXYL PALMITATE, CAROTENOIDS, BISABOLOL, TOCOPHERYL ACETATE (VE), SILICA DIMETHYL SILYLATE, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN

QUESTIONS OR COMMENTS

1-855-353-7320

SPF-20 FACE PRIMER 
octinoxate, oxybenzone, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BETA CAROTENE (UNII: 01YAE03M7J)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-108-51	1 in 1 BOX	05/12/2014	12/31/2017
1	NDC: 76354-108-21	13.7 g in 1 BOTTLE; 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	05/12/2014	12/31/2017

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

Revised: 5/2014

Document Id: 49749ac8-7ea1-4eae-8f6c-d4ad98eaae29

34390-5

Set id: e4e61b5a-6e41-47dd-b103-1408b75a3d65

Version: 3

Effective Time: 20140512

 

J. A. Cosmetics U.S. INC