SHISEIDO REVITALESSENCE SKIN GLOW PRIMER- avobenzone, octinoxate, and octocrylene emulsion

SHISEIDO REVITALESSENCE SKIN GLOW PRIMER by

Drug Labeling and Warnings

SHISEIDO REVITALESSENCE SKIN GLOW PRIMER 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 4.9%	Sunscreen
OCTOCRYLENE 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

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

WATER･ALCOHOL DENAT.･GLYCERIN･BUTYLENE GLYCOL･NIACINAMIDE･SILICA･ISODECYL NEOPENTANOATE･TRIETHYLHEXANOIN･GLYCERYL DIISOSTEARATE･PEG-60 HYDROGENATED CASTOR OIL･LACTOBACILLUS/RICE FERMENT･XANTHAN GUM･TOCOPHERYL ACETATE･POLYQUATERNIUM-51･LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL･SANGUISORBA OFFICINALIS ROOT EXTRACT･SODIUM ACETYLATED HYALURONATE･CITRUS JUNOS SEED EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･BATYL ALCOHOL･BEHENYL ALCOHOL･CARBOMER･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･POTASSIUM HYDROXIDE･ALCOHOL･ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER･TOCOPHEROL･TRISODIUM EDTA･SODIUM METAPHOSPHATE･SODIUM METABISULFITE･BHT･CHLORPHENESIN･PHENOXYETHANOL･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 - 30 mL Bottle Carton

SHISEIDO
GINZA TOKYO

REVITALESSENCE
SKIN GLOW

Primer

BROAD SPECTRUM
SPF 25

Sunscreen

Bio-BoostRED Technology

Fermented Kefir+
Niacinamide

30mL NET WT. 10Z.

INGREDIENTS AND APPEARANCE

SHISEIDO REVITALESSENCE SKIN GLOW PRIMER 
avobenzone, octinoxate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-894
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.77925 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.52733 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5585 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BATILOL (UNII: 39YR661C4U)
DOCOSANOL (UNII: 9G1OE216XY)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-894-60	1 in 1 CARTON	01/01/2023
1		30 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 DRUG	M020	01/01/2023

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-894) , MANUFACTURE(58411-894)