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

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.. 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, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, GLYCERIN, PENTAERYTHRITYL TETRAETHYLHEXANOATE, DIMETHICONE, SD ALCOHOL 40-B, BEHENYL ALCOHOL, TRANEXAMIC ACID, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, HYDROGENATED POLYDECENE, BEHENETH-20, SILICA, XANTHAN GUM, PEG/PPG-14/7 DIMETHYL ETHER, ERYTHRITOL, PEG/PPG-17/4 DIMETHYL ETHER, 2-O-ETHYL ASCORBIC ACID, GLUCOSYL HESPERIDIN, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, SODIUM HYALURONATE, STEARYL ALCOHOL, HYDROGENATED PALM OIL, ELAEIS GUINEENSIS (PALM) KERNEL OIL, ELAEIS GUINEENSIS (PALM) OIL, CELLULOSE GUM, SODIUM METAPHOSPHATE, TRISODIUM EDTA, BHT, ALUMINUM HYDROXIDE, SODIUM METABISULFITE, TOCOPHEROL, CITRIC ACID, 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 - 50 mL Jar Carton

SHISEIDO

WHITE LUCENT

Brightening
Protective Cream w
BROAD SPECTRUM
SPF 18
SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1284 mg  in 51.35 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3800 mg  in 51.35 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1027 mg  in 51.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCOSANOL (UNII: 9G1OE216XY)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BEHENETH-20 (UNII: BJ4GP2IFLN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED PALM OIL (UNII: 257THB963H)
PALM KERNEL OIL (UNII: B0S90M0233)
XANTHAN GUM (UNII: TTV12P4NEE)
PALM OIL (UNII: 5QUO05548Z)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ERYTHRITOL (UNII: RA96B954X6)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-280-50	1 in 1 CARTON	11/01/2012
1		51.35 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 52686-280-51	1 in 1 CARTON	11/01/2012
2	NDC: 52686-280-60	5.14 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 NOT FINAL	part352	11/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-280) , ANALYSIS(52686-280)