SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W- avobenzone, octinoxate, and octocrylene emulsion

SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W by

Drug Labeling and Warnings

SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	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

Warnings

For external use only

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

WATER, DIPROPYLENE GLYCOL, GLYCERIN, SD ALCOHOL 40-B, DIMETHICONE, SILICA, TRANEXAMIC ACID, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, HYDROGENATED POLYISOBUTENE, EUPHORBIA CERIFERA (CANDELILLA) WAX, PEG/PPG-14/7 DIMETHYL ETHER, ERYTHRITOL, PEG/PPG-17/4 DIMETHYL ETHER, XANTHAN GUM, 2-O-ETHYL ASCORBIC ACID, GLUCOSYL HESPERIDIN, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, SODIUM HYALURONATE, PEG/PPG-19/19 DIMETHICONE, BEHENYL ALCOHOL, PPG-8-CETETH-20, BEHENETH-20, TRISODIUM EDTA, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, STEARYL ALCOHOL, POTASSIUM HYDROXIDE, HYDROXYPROPYLCELLULOSE, BHT, SODIUM METABISULFITE, ALUMINUM HYDROXIDE, POLYSILICONE-2, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022
SHISEIDO DIST.
NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 75mL Bottle Carton

SHISEIDO

WHITE LUCENT

Brightening
Protective Emulsion w
BROAD SPECTRUM
SPF 18
SUNSCREEN

75mL 2.5 FL.OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W 
avobenzone, octinoxate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1915 mg  in 76.58 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5667 mg  in 76.58 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1532 mg  in 76.58 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CANDELILLA WAX (UNII: WL0328HX19)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENETH-20 (UNII: BJ4GP2IFLN)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
ERYTHRITOL (UNII: RA96B954X6)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
XANTHAN GUM (UNII: TTV12P4NEE)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-281-10	1 in 1 CARTON	11/01/2012
1		76.58 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 52686-281-11	1 in 1 CARTON	11/01/2012
2		7.15 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 NOT FINAL	part352	11/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-281) , ANALYSIS(52686-281)