SHISEIDO WASO COLOR-SMART DAY MOISTURIZER- octinoxate and titanium dioxide cream

SHISEIDO WASO COLOR-SMART DAY MOISTURIZER by

Drug Labeling and Warnings

SHISEIDO WASO COLOR-SMART DAY MOISTURIZER 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 4.2%	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∙DIMETHICONE∙GLYCERIN∙SD ALCOHOL 40-B∙PENTAERYTHRITYL TETRAETHYLHEXANOATE∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙TRIISOSTEARIN∙METHYL METHACRYLATE CROSSPOLYMER∙HYDROGENATED POLYDECENE∙DIPROPYLENE GLYCOL∙DISTEARDIMONIUM HECTORITE∙ERYTHRITOL∙SILICA∙TREHALOSE∙PEG-6∙PEG-32∙CAFFEINE∙BETAINE∙PEG/PPG-17/4 DIMETHYL ETHER∙DIPEPTIDE-15∙PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE∙PAEONIA ALBIFLORA ROOT EXTRACT∙LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT∙DAUCUS CAROTA SATIVA (CARROT) ROOT PROTOPLASTS∙CITRUS JUNOS SEED EXTRACT∙PPG-17∙ALUMINUM HYDROXIDE∙STEARIC ACID∙ISOSTEARIC ACID∙TRISODIUM EDTA∙BUTYLENE GLYCOL∙POLYESTER-1∙ALCOHOL∙SILICA DIMETHYL SILYLATE∙BHT∙ALUMINA∙TRIETHOXYCAPRYLYLSILANE∙SODIUM METABISULFITE∙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
SHI SEIDO
GINZA TOKYO

COLOR-SMART
DAY MOISTURIZER
BROAD SPECTRUM
SPF 30
SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WASO COLOR-SMART DAY MOISTURIZER 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-342
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3955 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2245 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIISOSTEARIN (UNII: 71503RH8KG)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ERYTHRITOL (UNII: RA96B954X6)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
CAFFEINE (UNII: 3G6A5W338E)
BETAINE (UNII: 3SCV180C9W)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
DIGLYCINE (UNII: 10525P22U0)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
LAMIUM ALBUM FLOWERING TOP (UNII: T95771X2XI)
CARROT (UNII: L56Z1JK48B)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
PPG-17 (UNII: OV0Q322E0U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOSTEARIC ACID (UNII: X33R8U0062)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-342-60	1 in 1 CARTON	08/01/2017
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	08/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-342) , analysis(58411-342)