Shiseido perfect refining foundationd10 cream

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

ACTIVE INGREDIENTS: Purpose
OCTINOXATE 2.9% Sunscreen
TITANIUM DIOXIDE 5.8% Sunscreen

Use

  • helps prevent sunburn

Warnings

Otc - do not use section

For external use only

Do not useon damaged or broken skin

Otc - when using section

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

Otc - stop use section

Stop use and ask a doctorif rash occurs

Otc - keep out of reach of children section

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 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, CYCLOMETHICONE, NYLON-12, SD ALCOHOL 40-B, DIETHYLHEXYL SUCCINATE, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, ERYTHRITOL, XYLITOL, POLYGLYCERYL-2 DIISOSTEARATE, PEG/PPG-36/41 DIMETHYL ETHER, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PAEONIA ALBIFLORA ROOT EXTRACT, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRISODIUM EDTA, DISTEARDIMONIUM HECTORITE, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BUTYLENE GLYCOL, TOCOPHEROL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, BARIUM SULFATE, SODIUM METABISULFITE, BHT, METHICONE, TETRADECENE, HYDROGEN DIMETHICONE, ALUMINA, PHENOXYETHANOL, BENZOIC ACID, IRON OXIDES, ZINC OXIDE, MICA, TITANIUM DIOXIDE,

Other information

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

Spl unclassified section

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

Ingredients and appearance - Product information

Shiseido perfect refining foundationd10 cream- Octinoxate and titanium dioxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52686-277
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 983 mgin 33.9 g
Titanium dioxide ( UNII: 15FIX9V2JP)( Titanium dioxide - UNII: 15FIX9V2JP ) 1966 mgin 33.9 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Dimethicone ( UNII: 92RU3N3Y1O)
Cyclomethicone ( UNII: NMQ347994Z)
Nylon-12 ( UNII: 446U8J075B)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Ferrosoferric oxide ( UNII: XM0M87F357)
Diethylhexyl succinate ( UNII: 69W9UMG3P8)
Glycerin ( UNII: PDC6A3C0OX)
Peg-10 dimethicone (600 cst) ( UNII: 8PR7V1SVM0)
Erythritol ( UNII: RA96B954X6)
Xylitol ( UNII: VCQ006KQ1E)
Aluminum hydroxide ( UNII: 5QB0T2IUN0)
Aluminum distearate ( UNII: 7P1HP1B9UI)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Edetate trisodium ( UNII: 420IP921MB)
Peg/ppg-36/41 dimethyl ether ( UNII: GZ406N3R9F)
Hyaluronate sodium ( UNII: YSE9PPT4TH)
Butylene glycol ( UNII: 3XUS85K0RA)
.alpha.-tocopherol ( UNII: H4N855PNZ1)
Zinc oxide ( UNII: SOI2LOH54Z)
Mica ( UNII: V8A1AW0880)
Dipentaerythrityl hexahydroxystearate ( UNII: 74J1X57U42)
Barium sulfate ( UNII: 25BB7EKE2E)
Sodium metabisulfite ( UNII: 4VON5FNS3C)
Lavender oil ( UNII: ZBP1YXW0H8)
Paeonia lactiflora root ( UNII: 3Z3866YW6P)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Methicone (20 cst) ( UNII: 6777U11MKT)
Tetradecene ( UNII: FW23481S7S)
Aluminum oxide ( UNII: LMI26O6933)
Benzoic acid ( UNII: 8SKN0B0MIM)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part352 USA

Shiseido perfect refining foundationd20 cream- Octinoxate and titanium dioxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52686-278
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 983 mgin 33.9 g
Titanium dioxide ( UNII: 15FIX9V2JP)( Titanium dioxide - UNII: 15FIX9V2JP ) 1966 mgin 33.9 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Dimethicone ( UNII: 92RU3N3Y1O)
Cyclomethicone ( UNII: NMQ347994Z)
Nylon-12 ( UNII: 446U8J075B)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Ferrosoferric oxide ( UNII: XM0M87F357)
Diethylhexyl succinate ( UNII: 69W9UMG3P8)
Glycerin ( UNII: PDC6A3C0OX)
Peg-10 dimethicone (600 cst) ( UNII: 8PR7V1SVM0)
Erythritol ( UNII: RA96B954X6)
Xylitol ( UNII: VCQ006KQ1E)
Aluminum hydroxide ( UNII: 5QB0T2IUN0)
Aluminum distearate ( UNII: 7P1HP1B9UI)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Edetate trisodium ( UNII: 420IP921MB)
Peg/ppg-36/41 dimethyl ether ( UNII: GZ406N3R9F)
Hyaluronate sodium ( UNII: YSE9PPT4TH)
Butylene glycol ( UNII: 3XUS85K0RA)
.alpha.-tocopherol ( UNII: H4N855PNZ1)
Zinc oxide ( UNII: SOI2LOH54Z)
Mica ( UNII: V8A1AW0880)
Dipentaerythrityl hexahydroxystearate ( UNII: 74J1X57U42)
Barium sulfate ( UNII: 25BB7EKE2E)
Sodium metabisulfite ( UNII: 4VON5FNS3C)
Lavender oil ( UNII: ZBP1YXW0H8)
Paeonia lactiflora root ( UNII: 3Z3866YW6P)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Methicone (20 cst) ( UNII: 6777U11MKT)
Tetradecene ( UNII: FW23481S7S)
Aluminum oxide ( UNII: LMI26O6933)
Benzoic acid ( UNII: 8SKN0B0MIM)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part352 USA

Shiseido perfect refining foundationd30 cream- Octinoxate and titanium dioxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52686-279
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 983 mgin 33.9 g
Titanium dioxide ( UNII: 15FIX9V2JP)( Titanium dioxide - UNII: 15FIX9V2JP ) 1966 mgin 33.9 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Dimethicone ( UNII: 92RU3N3Y1O)
Cyclomethicone ( UNII: NMQ347994Z)
Nylon-12 ( UNII: 446U8J075B)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Ferrosoferric oxide ( UNII: XM0M87F357)
Diethylhexyl succinate ( UNII: 69W9UMG3P8)
Glycerin ( UNII: PDC6A3C0OX)
Peg-10 dimethicone (600 cst) ( UNII: 8PR7V1SVM0)
Erythritol ( UNII: RA96B954X6)
Xylitol ( UNII: VCQ006KQ1E)
Aluminum hydroxide ( UNII: 5QB0T2IUN0)
Aluminum distearate ( UNII: 7P1HP1B9UI)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Edetate trisodium ( UNII: 420IP921MB)
Peg/ppg-36/41 dimethyl ether ( UNII: GZ406N3R9F)
Hyaluronate sodium ( UNII: YSE9PPT4TH)
Butylene glycol ( UNII: 3XUS85K0RA)
.alpha.-tocopherol ( UNII: H4N855PNZ1)
Zinc oxide ( UNII: SOI2LOH54Z)
Mica ( UNII: V8A1AW0880)
Dipentaerythrityl hexahydroxystearate ( UNII: 74J1X57U42)
Barium sulfate ( UNII: 25BB7EKE2E)
Sodium metabisulfite ( UNII: 4VON5FNS3C)
Lavender oil ( UNII: ZBP1YXW0H8)
Paeonia lactiflora root ( UNII: 3Z3866YW6P)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Methicone (20 cst) ( UNII: 6777U11MKT)
Tetradecene ( UNII: FW23481S7S)
Aluminum oxide ( UNII: LMI26O6933)
Benzoic acid ( UNII: 8SKN0B0MIM)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part352 USA

Labeler - SHISEIDO AMERICA INC.( 782677132)

Establishment

Name ID/FEI Business Operations
SHISEIDO AMERICA INC. 782677132 manufacture( 52686-277, 52686-278, 52686-279), analysis( 52686-277, 52686-278, 52686-279)

Principal display panel - 30ml d 10 tube carton

S HI S EIDO

D 10

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1 FL. OZ.

Principal display panel - 30ml d 20 tube carton

S HI S EIDO

D 20

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1 FL. OZ.

Principal display panel - 30ml d 30 tube carton

S HI S EIDO

D 30

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1 FL. OZ.