Label: SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 1 LIGHT- octinoxate and titanium dioxide cream
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 2 MEDIUM- octinoxate and titanium dioxide cream
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 3 MEDIUM DEEP- octinoxate and titanium dioxide cream
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 4 DEEP- octinoxate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52686-260-60, 52686-261-60, 52686-262-60, 52686-263-60 - Packager: SHISEIDO AMERICA INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 19, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
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Inactive Ingredients
WATER, CYCLOMETHICONE, GLYCERIN, DIMETHICONE, TALC, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, XYLITOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, TRIMETHYLSILOXYSILICATE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, DISTEARDIMONIUM HECTORITE, ERYTHRITOL, TREHALOSE, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, HYDROXYPROPYL CYCLODEXTRIN, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, SODIUM HYALURONATE, CITRUS JUNOS SEED EXTRACT, PHYTOSTERYL MACADAMIATE, ISOSTEARIC ACID, CALCIUM STEARATE, GLYCERYL DIISOSTEARATE, ALCOHOL, TRISODIUM EDTA, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BHT, TOCOPHEROL, PEG-60 GLYCERYL ISOSTEARATE, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1 LIGHT
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2 MEDIUM
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3 MEDIUM DEEP
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4 DEEP
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INGREDIENTS AND APPEARANCE
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 1 LIGHT
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 1149 mg in 60.45 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 7556 mg in 60.45 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIPROPYLENE GLYCOL (UNII: E107L85C40) XYLITOL (UNII: VCQ006KQ1E) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ERYTHRITOL (UNII: RA96B954X6) TREHALOSE (UNII: B8WCK70T7I) THIOTAURINE (UNII: NQZ2D7AO62) MENTHA PIPERITA LEAF (UNII: A389O33LX6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CITRUS JUNOS SEED (UNII: UY43O1Q45N) ISOSTEARIC ACID (UNII: X33R8U0062) CALCIUM STEARATE (UNII: 776XM7047L) ALCOHOL (UNII: 3K9958V90M) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:52686-260-60 1 in 1 CARTON 1 60.45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2008 SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 2 MEDIUM
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-261 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 1149 mg in 60.45 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 7556 mg in 60.45 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIPROPYLENE GLYCOL (UNII: E107L85C40) XYLITOL (UNII: VCQ006KQ1E) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ERYTHRITOL (UNII: RA96B954X6) TREHALOSE (UNII: B8WCK70T7I) THIOTAURINE (UNII: NQZ2D7AO62) MENTHA PIPERITA LEAF (UNII: A389O33LX6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CITRUS JUNOS SEED (UNII: UY43O1Q45N) ISOSTEARIC ACID (UNII: X33R8U0062) CALCIUM STEARATE (UNII: 776XM7047L) ALCOHOL (UNII: 3K9958V90M) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:52686-261-60 1 in 1 CARTON 1 60.45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2008 SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 3 MEDIUM DEEP
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-262 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 1149 mg in 60.45 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 7556 mg in 60.45 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIPROPYLENE GLYCOL (UNII: E107L85C40) XYLITOL (UNII: VCQ006KQ1E) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ERYTHRITOL (UNII: RA96B954X6) TREHALOSE (UNII: B8WCK70T7I) THIOTAURINE (UNII: NQZ2D7AO62) MENTHA PIPERITA LEAF (UNII: A389O33LX6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CITRUS JUNOS SEED (UNII: UY43O1Q45N) ISOSTEARIC ACID (UNII: X33R8U0062) CALCIUM STEARATE (UNII: 776XM7047L) ALCOHOL (UNII: 3K9958V90M) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:52686-262-60 1 in 1 CARTON 1 60.45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2008 SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 4 DEEP
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 1149 mg in 60.45 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 7556 mg in 60.45 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIPROPYLENE GLYCOL (UNII: E107L85C40) XYLITOL (UNII: VCQ006KQ1E) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ERYTHRITOL (UNII: RA96B954X6) TREHALOSE (UNII: B8WCK70T7I) THIOTAURINE (UNII: NQZ2D7AO62) MENTHA PIPERITA LEAF (UNII: A389O33LX6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CITRUS JUNOS SEED (UNII: UY43O1Q45N) ISOSTEARIC ACID (UNII: X33R8U0062) CALCIUM STEARATE (UNII: 776XM7047L) ALCOHOL (UNII: 3K9958V90M) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:52686-263-60 1 in 1 CARTON 1 60.45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2008 Labeler - SHISEIDO AMERICA INC. (782677132) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-260, 52686-261, 52686-262, 52686-263) , ANALYSIS(52686-260, 52686-261, 52686-262, 52686-263) Establishment Name Address ID/FEI Business Operations Davlyn Industries Inc 624436254 MANUFACTURE(52686-260, 52686-261, 52686-262, 52686-263)
