SHISEIDO WASO SHIKULIME COLOR CONTROL- avobenzone, homosalate, octisalate, octocrylene, cream

SHISEIDO WASO SHIKULIME COLOR CONTROL by

Drug Labeling and Warnings

SHISEIDO WASO SHIKULIME COLOR CONTROL 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
• AVOBENZONE 2.3%: Sunscreen
• HOMOSALATE 10%: Sunscreen
• OCTISALATE 5.0%: 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

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 Co

Directions

For suncreen use:

• 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･BUTYLENE GLYCOL･CAPRYLYL METHICONE･SILICA･GLYCERIN･SD ALCOHOL 40-B･CETYL PEG/PPG-10/1 DIMETHICONE･DIPROPYLENE GLYCOL･ZEA MAYS (CORN) STARCH･POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER･ERYTHRITOL･C30-45 ALKYL METHICONE･PEG-150･TREHALOSE･SODIUM CHLORIDE･PYRUS MALUS (APPLE) FRUIT WATER･CITRUS DEPRESSA PEEL EXTRACT･C30-45 OLEFIN･CELLULOSE GUM･TRISODIUM EDTA･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･POLYESTER-1･SILICA DIMETHYL SILYLATE･ALUMINUM HYDROXIDE･ALCOHOL･POLYSILICONE-2･SODIUM METABISULFITE･PHENOXYETHANOL･TITANIUM DIOXIDE･IRON OXIDES･MICA･

Other Information

• protect this product in this container fro excessive heat and direct sun.
• cap contains natural materials that may change color/texture over time. This doesn't affect product quality. Wipe any liquid or dirt off the cap and store in a dry area.

Questions or Comments?

Call toll free-1-800-906-7503

PRINCIPLE DISPLAY PANEL- 50 mL

WASO

SHISEIDO

GINZA TOKYO

SHIKULIME

COLOR CONTROL

OIL-FREE MOISTURIZER

BROAD SPECTRUM

SPF 30

SUNSCREEN

BARRIER BALANCE

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WASO SHIKULIME COLOR CONTROL 
avobenzone, homosalate, octisalate, octocrylene, cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-965
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.24959 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.433 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	2.7165 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7165 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
SILICA (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ZEA MAYS (CORN) STARCH (UNII: O8232NY3SJ)
ERYTHRITOL (UNII: RA96B954X6)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
PEG-150 (UNII: Q0JET65GEL)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
APPLE FRUIT OIL (UNII: 9NT987I3A8)
TANGERINE PEEL (UNII: JU3D414057)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
CELLULOSE GUM (UNII: K679OBS311)
TRISODIUM EDTA (UNII: 420IP921MB)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALCOHOL (UNII: 3K9958V90M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-965-60	1 in 1 BOX	02/06/2028
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	M020	02/01/2021

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-965) , analysis(58411-965)