SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY- avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone cream

SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY by

Drug Labeling and Warnings

SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY 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 2.0%	Sunscreen
HOMOSALATE 5.0%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
OXYBENZONE 1.5%	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

WATERGLYCERINDIPROPYLENE GLYCOLBUTYLENE GLYCOLBEHENYL ALCOHOLSD ALCOHOL 40-BSILICADIMETHICONEISODODECANEISOHEXADECANESORBITOLBEHENETH-20MYRISTYL MYRISTATEPHYTOSTERYL MACADAMIATEERYTHRITOLXANTHAN GUMTOCOPHERYL ACETATEPEG/PPG-14/7 DIMETHYL ETHERPEG/PPG-17/4 DIMETHYL ETHERCAFFEINESAPINDUS MUKOROSSI PEEL EXTRACTANGELICA KEISKEI LEAF/STEM EXTRACTCAMELLIA SINENSIS LEAF EXTRACTCITRUS JUNOS SEED EXTRACTZIZIPHUS JUJUBA FRUIT EXTRACTEUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACTCURCUMA LONGA (TURMERIC) RHIZOME EXTRACTPOLYQUATERNIUM-51SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACTCHLORELLA VULGARIS EXTRACTPPG-17STEARYL ALCOHOLBEHENETH-30ALCOHOLCARBOMERCELLULOSE GUMTRISODIUM EDTAHDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERSODIUM CITRATEBHTSODIUM METAPHOSPHATEPOTASSIUM HYDROXIDECITRIC ACIDTOCOPHEROLPPG-3 DIPIVALATESODIUM METABISULFITEPHENOXYETHANOLFRAGRANCEIRON 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 Jar Carton

SHISEIDO
GINZA TOKYO

Benefiance

Wrinkle Smoothing Day Cream

BROAD SPECTRUM
SPF 23
SUNSCREEN

ReNeura Technology+™

Wrinkles

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY 
avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1032 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2580 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3818 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1548 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	774 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DOCOSANOL (UNII: 9G1OE216XY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
SORBITOL (UNII: 506T60A25R)
BEHENETH-20 (UNII: BJ4GP2IFLN)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
ERYTHRITOL (UNII: RA96B954X6)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
CAFFEINE (UNII: 3G6A5W338E)
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)
ANGELICA KEISKEI TOP (UNII: AP628M4TQO)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
JUJUBE FRUIT (UNII: G55HNL2C70)
TURMERIC (UNII: 856YO1Z64F)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
PPG-17 (UNII: OV0Q322E0U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BEHENETH-30 (UNII: 21Z34J9KN8)
ALCOHOL (UNII: 3K9958V90M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE TRISODIUM (UNII: 420IP921MB)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-439-50	1 in 1 CARTON	06/01/2018
1		50 mL in 1 JAR; 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	06/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-439) , ANALYSIS(58411-439)