SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N- avobenzone, octinoxate, octocrylene, and oxybenzone cream

SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N by

Drug Labeling and Warnings

SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, 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 3.0%	Sunscreen
OXYBENZONE 1.0%	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

• 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

WATERSD ALCOHOL 40-BDIMETHICONEDIPROPYLENE GLYCOLDIISOPROPYL SEBACATEGLYCERINPEG-60 HYDROGENATED CASTOR OILPOTASSIUM METHOXYSALICYLATEXANTHAN GUMPEG/PPG-14/7 DIMETHYL ETHERTOCOPHERYL ACETATE2-O-ETHYL ASCORBIC ACIDASCORBYL TETRAISOPALMITATESODIUM HYALURONATEPAEONIA SUFFRUTICOSA ROOT EXTRACTCRATAEGUS MONOGYNA FLOWER EXTRACTPOLYQUATERNIUM-51REHMANNIA CHINENSIS ROOT EXTRACTUNCARIA GAMBIR EXTRACTHOUTTUYNIA CORDATA EXTRACTPPG-17PEG-240/HDI COPOLYMER BIS-DECYLTETRADECETH-20 ETHERTRIETHANOLAMINESILICAISOSTEARIC ACIDBUTYLENE GLYCOLCARBOMERACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMERALCOHOLBHTSODIUM METAPHOSPHATEDISODIUM EDTATOCOPHEROLZINC OXIDESODIUM METABISULFITEALUMINAPRUNUS YEDOENSIS LEAF EXTRACTMETHYLPARABENETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEMICAIRON 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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SHI SEIDO

WHITE LUCENT

All Day Brightener

BROAD SPECTRUM
SPF 23

SUNSCREEN

PROAPPROACH×2

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N 
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1283 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3796 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1539 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	513 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
PPG-17 (UNII: OV0Q322E0U)
TROLAMINE (UNII: 9O3K93S3TK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ZINC OXIDE (UNII: SOI2LOH54Z)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-295-60	1 in 1 CARTON	02/01/2017
1		50 mL 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	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-295) , analysis(58411-295)