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

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 4.5% 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

Active ingredients	Purpose
OCTINOXATE 7.4%	Sunscreen
TITANIUM DIOXIDE 4.5%	Sunscreen

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

SHISEIDO
GINZA TOKYO

COLOR-SMART
DAY MOISTURIZER
BROAD SPECTRUM
SPF 30
SUNSCREEN

50mL NET WT.1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-456
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3955 mg in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2405 mg in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIISOSTEARIN (UNII: 71503RH8KG)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
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)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 58411-456-60	1 in 1 CARTON	02/01/2019
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-456) , ANALYSIS(58411-456)