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

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

PURPOSE

• Active Ingredients: Purpose
• Avobenzone 2.5%: Sunscreen
• Homosalate 4.5%: Sunscreen
• Octisalate 4.5%: Sunscreen
• Octocrylene 5.0%: Sunscreen

Uses

• helps prevent sunburn

Warnings

For external use only

DO NOT USE

Do not use

• on damaged or broken skin

WHEN USING

When using this product

• keep out of eyes. Rinse with water to remove

STOP USE

Stop use and ask a doctor if

• rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact 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 increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months: ask a doctor

Other information

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

INACTIVE INGREDIENT

Water･Glycerin･Dipropylene Glycol･Dimethicone･Alcohol Denat.･C12-15 Alkyl Benzoate･Behenyl Alcohol･Butylene Glycol･Silica･Diphenylsiloxy Phenyl Trimethicone･Isododecane･Sorbitol･Stearyl Alcohol･Phytosteryl Macadamiate･Erythritol･Tocopheryl Acetate･PEG/PPG-14/7 Dimethyl Ether･PEG/PPG-17/4 Dimethyl Ether･Xanthan Gum･Caffeine･Sapindus Mukorossi Peel Extract･Angelica Keiskei Leaf/Stem Extract･Camellia Sinensis Leaf Extract･Citrus Junos Seed Extract･Ziziphus Jujuba Fruit Extract･Eucheuma Serra/Grateloupia Sparsa/Saccharina Angustata/Ulva Linza/Undaria Pinnatifida Extract･Potentilla Erecta Root Extract･Polyquaternium-51･Saccharina Angustata/Undaria Pinnatifida Extract･Chlorella Vulgaris Extract･Beheneth-20･Batyl Alcohol･Alcohol･Succinoglycan･Trisodium EDTA･Sodium Citrate･Sodium Metaphosphate･BHT･Citric Acid･Sodium Metabisulfite･PPG-3 Dipivalate･Tocopherol･Phenoxyethanol･Fragrance･Iron Oxides･

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 25 SUNSCREEN

Target wrinkles

50mL NET. WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY 
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.295 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.331 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	2.331 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.59 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICA (UNII: ETJ7Z6XBU4)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ISODODECANE (UNII: A8289P68Y2)
SORBITOL (UNII: 506T60A25R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ERYTHRITOL (UNII: RA96B954X6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
XANTHAN GUM (UNII: TTV12P4NEE)
CAFFEINE (UNII: 3G6A5W338E)
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)
ANGELICA KEISKEI WHOLE (UNII: 40RUH3S7RZ)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ZIZIPHUS JUJUBA WHOLE (UNII: AQG914O70P)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
BEHENETH-20 (UNII: BJ4GP2IFLN)
BATYL ALCOHOL (UNII: 39YR661C4U)
SUCCINOGLYCAN (AGROBACTERIUM TUMEFACIENS) (UNII: YP632MQS35)
TRISODIUM EDTA (UNII: 420IP921MB)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-017-50	1 in 1 CARTON	05/01/2026
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 Drug	M020	05/01/2026

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-017) , analysis(58411-017)