SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP10- octinoxate and titanium dioxide powder SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP20- octinoxate and titanium dioxide powder SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP30- octinoxate and titanium dioxide powder SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP40- octinoxate and titanium dioxide powder SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP50- octinoxate and titanium dioxide powder SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP60- octinoxate and titanium dioxide powder SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP70- octinoxate and titanium dioxide powder

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) by

Drug Labeling and Warnings

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
OCTINOXATE 6.9%	Sunscreen
TITANIUM DIOXIDE 5.5%	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.

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

PETROLATUM, TALC, POLYMETHYL METHACRYLATE, NYLON-12, SILICA, SYNTHETIC WAX, HYDROGENATED POLYDECENE, SORBITAN SESQUIISOSTEARATE, ZINC MYRISTATE, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, THIOTAURINE, STEARYL GLYCYRRHETINATE, METHICONE, DIMETHICONE, DIMETHICONE/METHICONE COPOLYMER, GLYCERIN, TOCOPHEROL, BHT, ETHYLPARABEN, FRAGRANCE, MICA, TITANIUM DIOXIDE, IRON OXIDES

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 DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton SP10

SHI SEIDO

36

Sun Protection
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton SP20

SHI SEIDO

36

Sun Protection
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton SP30

SHI SEIDO

36

Sun Protection
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton SP40

SHI SEIDO

36

Sun Protection
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton SP50

SHI SEIDO

36

Sun Protection
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton SP60

SHI SEIDO

36

Sun Protection
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton SP70

SHI SEIDO

36

Sun Protection
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL)  SP10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	828 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	660 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-295-30	1 in 1 CARTON	01/01/2004
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL)  SP20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-296
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	828 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	660 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-296-30	1 in 1 CARTON	01/01/2004
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL)  SP30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-297
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	828 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	660 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-297-30	1 in 1 CARTON	01/01/2004
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL)  SP40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-298
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	828 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	660 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-298-30	1 in 1 CARTON	01/01/2004
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL)  SP50
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-299
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	828 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	660 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-299-30	1 in 1 CARTON	01/01/2004
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL)  SP60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	828 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	660 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-300-30	1 in 1 CARTON	01/01/2004
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL)  SP70
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	828 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	660 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-301-30	1 in 1 CARTON	01/01/2004
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2004

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52686-295, 52686-296, 52686-297, 52686-298, 52686-299, 52686-300, 52686-301) , analysis(52686-295, 52686-296, 52686-297, 52686-298, 52686-299, 52686-300, 52686-301)