SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY- avobenzone, octinoxate, octocrylene, and homosalate cream

SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY by

Drug Labeling and Warnings

SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING 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 2.5%	Sunscreen
Octinoxate 7.4%	Sunscreen
Octocrylene 3.0%	Sunscreen
Homosalate 5.0%	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
• children under 6 months: ask a doctor
• 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

Inactive Ingredients

WATER▪DIPROPYLENE GLYCOL▪GLYCERIN▪DIMETHICONE▪SD ALCOHOL 40-B▪BEHENYL ALCOHOL▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪HYDROGENATED POLYDECENE▪;BEHENETH-20▪SILICA▪ISOHEXADECANE▪STEARYL ALCOHOL▪C30-45 ALKYL METHICONE▪POTASSIUM METHOXYSALICYLATE▪XANTHAN GUM▪ERYTHRITOL▪TOCOPHERYL ACETATE▪PEG/PPG-14/7 DIMETHYL ETHER▪PEG/PPG-17/4 DIMETHYL ETHER▪ROSA DAMASCENA FLOWER WATER▪PHYTOSTERYL MACADAMIATE▪CAFFEINE▪LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL▪ANGELICA KEISKEI LEAF/STEM EXTRACT▪OLEA EUROPAEA (OLIVE) LEAF EXTRACT▪LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT▪INOSITOL▪CAMELLIA SINENSIS LEAF EXTRACT▪CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT▪ZIZIPHUS JUJUBA FRUIT EXTRACT▪ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT▪HYDROLYZED SILK▪POLYQUATERNIUM-51▪BUPLEURUM FALCATUM ROOT EXTRACT▪PPG-17▪C30-45 OLEFIN▪BEHENETH-30▪BUTYLENE GLYCOL▪POLYVINYL ALCOHOL▪CELLULOSE GUM▪BHT▪SODIUM METAPHOSPHATE▪TRISODIUM EDTA▪ALCOHOL▪TOCOPHEROL▪PPG-3 DIPIVALATE▪SODIUM METABISULFITE▪CELLULOSE▪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 Jar Carton

SHISEIDO
GINZA TOKYO

VITAL PERFECTION
Uplifting and Firming Day Cream

BROAD SPECTRUM
SPF 30
SUNSCREEN

ReNeura Technology++™
Lift - Firm - Brighten

50mL NET WT. 1.7 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY 
avobenzone, octinoxate, octocrylene, and homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-479
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.278 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.785 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.534 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.557 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCOSANOL (UNII: 9G1OE216XY)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
BEHENETH-20 (UNII: BJ4GP2IFLN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOHEXADECANE (UNII: 918X1OUF1E)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
XANTHAN GUM (UNII: TTV12P4NEE)
ERYTHRITOL (UNII: RA96B954X6)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
CAFFEINE (UNII: 3G6A5W338E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ANGELICA KEISKEI TOP (UNII: AP628M4TQO)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
LAMIUM ALBUM FLOWERING TOP (UNII: T95771X2XI)
INOSITOL (UNII: 4L6452S749)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SAFFLOWER (UNII: 4VBL71TY4Y)
JUJUBE FRUIT (UNII: G55HNL2C70)
ROSEMARY (UNII: IJ67X351P9)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
PPG-17 (UNII: OV0Q322E0U)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
BEHENETH-30 (UNII: 21Z34J9KN8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
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: 58411-479-50	1 in 1 CARTON	01/01/2020
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	01/01/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-479) , ANALYSIS(58411-479)