SHISEIDO BENEFIANCE WRINKLERESIST24 DAY- avobenzone, octinoxate, and octocrylene cream

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY by

Drug Labeling and Warnings

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZON 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 two 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∙GLYCERIN∙DIPROPYLENE GLYCOL∙BUTYLENE GLYCOL∙PHENYL TRIMETHICONE∙HYDROGENATED POLYDECENE∙SORBITOL∙MYRISTYL MYRISTATE∙DIMETHICONE∙SD ALCOHOL 40-B∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙PETROLATUM∙STEARYL ALCOHOL∙STEARIC ACID∙SILICA∙BENTONITE∙PALMITIC ACID∙XANTHAN GUM∙PEG/PPG-17/4 DIMETHYL ETHER∙PHYTOSTERYL MACADAMIATE∙TOCOPHERYL ACETATE∙SAPINDUS MUKUROSSI PEEL EXTRACT∙UNCARIA GAMBIR EXTRACT∙SODIUM ACETYLATED HYALURONATE∙HYDROXYPROLINE∙THYMUS SERPILLUM EXTRACT∙CHLORELLA VULGARIS EXTRACT∙PEG-5 GLYCERYL STEARATE∙GLYCERYL STEARATE SE∙TRISODIUM EDTA∙POTASSIUM HYDROXIDE∙SODIUM METAPHOSPHATE∙AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER∙ALCOHOL∙SODIUM METABISULFITE∙BHT∙TOCOPHEROL∙PHENOXYETHANOL∙FRAGRANCE∙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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

SHISEIDO

BENEFIANCE
WrinkleResist24
Day Cream
BROAD SPECTRUM
SPF 18
SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY 
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-629
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.28 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.85 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.02 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
SORBITOL (UNII: 506T60A25R)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PALMITIC ACID (UNII: 2V16EO95H1)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYDROXYPROLINE (UNII: RMB44WO89X)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE TRISODIUM (UNII: 420IP921MB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ALCOHOL (UNII: 3K9958V90M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
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: 58411-629-10	1 in 1 CARTON	01/01/2021
1		50 mL 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 DRUG	M020	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)