SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OIL-FREE- octinoxate and titanium dioxide emulsion

shiseido waso color-smart day moisturizer oil-free by

Drug Labeling and Warnings

shiseido waso color-smart day moisturizer oil-free 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
OCTINOXATE 7.4%	Sunscreen
TITANIUM DIOXIDE 5.3%	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.

Flammable. Do not use near heat, flame, or while smoking.

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∙CYCLOPENTASILOXANE∙SD ALCOHOL 40-B GLYCERIN∙METHYL METHACRYLATE CROSSPOLYMER∙DIMETHICONE∙PEG-10 DIMETHICONE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙POLYMETHYLSILSESQUIOXANE∙TALC∙ERYTHRITOL∙SILICA∙TREHALOSE∙DISTEARDIMONIUM HECTORITE∙TRIMETHYLSILOXYSILICATE∙CAFFEINE∙BETAINE∙PEG/PPG-17/4 DIMETHYL ETHER∙PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE∙DIPEPTIDE-15∙ERIOBOTRYA JAPONICA LEAF PROTOPLASTS∙PAEONIA ALBIFLORA ROOT EXTRACT∙LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT∙CITRUS JUNOS SEED EXTRACT∙ERIOBOTRYA JAPONICA LEAF EXTRACT∙ALUMINUM HYDROXIDE∙STEARIC ACID ISOSTEARIC ACID∙BUTYLENE GLYCOL∙TRISODIUM EDTA∙POLYESTER-1 ALCOHOL∙SILICA DIMETHYL SILYLATE∙ALUMINA∙TRIETHOXYCAPRYLYLSILANE HYDROGEN DIMETHICONE∙BHT∙TOCOPHEROL∙PHENOXYETHANOL∙BENZOIC ACID∙FRAGRANCE TITANIUM DIOXIDE IRON OXIDES MICA∙

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 Tube Carton

WASO

SHISEIDO
GINZA TOKYO

COLOR-SMART
DAY MOISTURIZER
OIL-FREE
BROAD SPECTRUM
SPF 30
SUNSCREEN

50mL NET WT. 1.9 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OIL-FREE 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-457
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4177 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2992 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
ERYTHRITOL (UNII: RA96B954X6)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
CAFFEINE (UNII: 3G6A5W338E)
BETAINE (UNII: 3SCV180C9W)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
DIGLYCINE (UNII: 10525P22U0)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
LAMIUM ALBUM FLOWERING TOP (UNII: T95771X2XI)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALCOHOL (UNII: 3K9958V90M)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-457-60	1 in 1 CARTON	02/01/2019
1		50 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 FINAL	part352	02/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-457) , ANALYSIS(58411-457)