SPF-45 SUNSCREEN by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

SPF-45 SUNSCREEN by

Drug Labeling and Warnings

SPF-45 SUNSCREEN 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-45 SUNSCREEN- titanium dioxide, zinc oxide powder 
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.

----------

Active Ingredient:

TITANIUM DIOXIDE 23.3%

ZINC OXIDE 18.7%

Purpose:

SUNSCREEN

Uses:

• ​HELPS 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 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 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.
• STORE AT ROOM TEMPERATURE 15°C-30°C (59°F-86°F)

Inactive Ingredient:

MICA, TALC, BISMUTH OXYCHLORIDE, BORON NITRIDE, SILICA, VITIS VINEFERA (GRAPE) SEED EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, RETINYL PALMITATE (VA), TOCOPHERYL ACETATE (VE), MAGNESIUM ASCORBYL PHOSPHATE (VC), SODIUM DEHYDROACETATE

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499), MAGNESIUM VIOLET (CI 77742)

QUESTIONS OR COMMENTS

1-855-353-7320

SPF-45 SUNSCREEN 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.7   in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GRAPE (UNII: 6X543N684K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-107-51	1 in 1 BOX	05/12/2014	12/31/2017
1	NDC: 76354-107-31	10 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	05/12/2014	12/31/2017

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

Revised: 5/2014

Document Id: 2ce1c296-a848-4680-9e6e-49d191faf71e

34390-5

Set id: eaf3f9ce-c9f6-4aba-80d9-457b13e57202

Version: 4

Effective Time: 20140512