SHISEIDO WASO COLOR-SMART DAY MOISTURIZER- octinoxate, 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

PURPOSE

• 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

Do not useon damaged or broken skin

WHEN USING

When using this productkeep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctorif rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DO NOT USE

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

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sun screen 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. - 2p.m.
      -wear long-sleeve shirts, pant, 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

PRINCIPLE DISPLAY PANEL- 50 mL

WASO

SHISEIDO

GINZA TOKYO

COLOR-SMART

DAY MOISTURIZER

OIL- FREE

BROAD SPECTRUM

SPF-30

SUNSCREEN

50 mL NET WT.1.9 OZ

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-966
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.255 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.0475 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TALC (UNII: 7SEV7J4R1U)
ERYTHRITOL (UNII: RA96B954X6)
SILICA (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BETAINE (UNII: 3SCV180C9W)
CAFFEINE (UNII: 3G6A5W338E)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
DIPEPTIDE-15 (UNII: 10525P22U0)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
LAMIUM ALBUM FLOWERING TOP (UNII: T95771X2XI)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRISODIUM EDTA (UNII: 420IP921MB)
ALCOHOL (UNII: 3K9958V90M)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINA (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BHT (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-966-60	1 in 1 BOX	09/01/2018
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 Drug	M040	09/01/2018

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-966) , analysis(58411-966)