SHISEIDO WASO SHIKULIME COLOR CONTROL OIL-FREE MOISTURIZER Broad Spectrum SPF 30

SHISEIDO WASO SHIKULIME COLOR CONTROL oil-free MOISTURIZER Broad Spectrum SPF 30 by

Drug Labeling and Warnings

SHISEIDO WASO SHIKULIME COLOR CONTROL oil-free MOISTURIZER Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SHISEIDO WASO SHIKULIME COLOR CONTROL OIL-FREE MOISTURIZER BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, and octocrylene cream 
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SHISEIDO WASO SHIKULIME COLOR CONTROL OIL-FREE MOISTURIZER Broad Spectrum SPF 30

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.3%Sunscreen
HOMOSALATE 10.0%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 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.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every two 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▪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▪ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL▪LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL▪SALVIA OFFICINALIS (SAGE) OIL▪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▪CITRUS AURANTIUM DULCIS (ORANGE) OIL▪SODIUM METABISULFITE▪PHENOXYETHANOL▪TITANIUM DIOXIDE▪IRON OXIDES▪MICA▪ <M094881-811>

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

SHIKULIME

COLOR CONTROL
OIL-FREE MOISTURIZER

BROAD SPECTRUM
SPF 30
SUNSCREEN

BARRIER BALANCE

SHIKUWASA
OKINAWA

50mL NET WT. 1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
SHISEIDO WASO SHIKULIME COLOR CONTROL OIL-FREE MOISTURIZER BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58411-614
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.4 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.72 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.4 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ERYTHRITOL (UNII: RA96B954X6)  
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
TREHALOSE (UNII: B8WCK70T7I)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
C30-45 OLEFIN (UNII: 6DWD51M0O8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
APPLE FRUIT OIL (UNII: 9NT987I3A8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
MICA (UNII: V8A1AW0880)  
POLYESTER-10 (UNII: 212N9O2MMZ)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALCOHOL (UNII: 3K9958V90M)  
ORANGE OIL (UNII: AKN3KSD11B)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SAGE OIL (UNII: U27K0H1H2O)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TANGERINE PEEL (UNII: JU3D414057)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58411-614-601 in 1 CARTON01/01/202101/01/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/202101/01/2021
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 7/2021
Document Id: 0fd33d45-1351-4d90-8d6f-4dc4f4a84c51
Set id: b80a1c11-79c7-4c31-9b98-40ecaf7c583a
Version: 2
Effective Time: 20210707