Label: SHISEIDO SYNCHRO SKIN TINTED 1 VERY LIGHT- octinoxate and titanium dioxide cream
SHISEIDO SYNCHRO SKIN TINTED 2 LIGHT- octinoxate and titanium dioxide cream
SHISEIDO SYNCHRO SKIN TINTED 3 MEDIUM- octinoxate and titanium dioxide cream
SHISEIDO SYNCHRO SKIN TINTED 4 MEDIUM DARK- octinoxate and titanium dioxide cream
SHISEIDO SYNCHRO SKIN TINTED 5 DARK- octinoxate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-440-60, 58411-441-60, 58411-442-60, 58411-443-60, view more58411-444-60 - Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 9, 2018
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
-
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
-
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•ISOHEXADECANE•PROPANEDIOL•ISOPROPYL MYRISTATE•TREHALOSE•ISODODECANE•ISOSTEARIC ACID•GLYCERIN•SILICA•POLYQUATERNIUM-51•THYMUS SERPYLLUM EXTRACT•SODIUM ACETYLATED HYALURONATE•CAMELLIA SINENSIS LEAF EXTRACT•METHYL METHACRYLATE/ACRYLONITRILE COPOLYMER•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•PEG-60 GLYCERYL ISOSTEARATE•AGAR•SORBITAN SESQUIISOSTEARATE•CELLULOSE GUM•ALUMINUM HYDROXIDE•POLYSILICONE-2•SODIUM CITRATE•ALCOHOL•MAGNESIUM HYDROXIDE•SUCCINOGLYCAN•BHT•BUTYLENE GLYCOL•TOCOPHEROL•CITRIC ACID•METHYL METHACRYLATE CROSSPOLYMER•SODIUM METABISULFITE•HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT•TALC•ALUMINA•POLYMETHYLSILSESQUIOXANE•ISOBUTANE•ISOPENTANE•PHENOXYETHANOL•TITANIUM DIOXIDE•IRON OXIDES•MICA•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 1 Very Light
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 2 Light
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 3 Medium
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 4 Medium Dark
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 5 Dark
-
INGREDIENTS AND APPEARANCE
SHISEIDO SYNCHRO SKIN TINTED 1 VERY LIGHT
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-440 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1248 mg in 40 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2625 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TREHALOSE (UNII: B8WCK70T7I) ISODODECANE (UNII: A8289P68Y2) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) AGAR, UNSPECIFIED (UNII: 89T13OHQ2B) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ISOBUTANE (UNII: BXR49TP611) ISOPENTANE (UNII: ZH67814I0O) 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:58411-440-60 1 in 1 CARTON 06/01/2018 1 40 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 FINAL part352 06/01/2018 SHISEIDO SYNCHRO SKIN TINTED 2 LIGHT
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-441 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1248 mg in 40 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2625 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TREHALOSE (UNII: B8WCK70T7I) ISODODECANE (UNII: A8289P68Y2) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) AGAR, UNSPECIFIED (UNII: 89T13OHQ2B) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ISOBUTANE (UNII: BXR49TP611) ISOPENTANE (UNII: ZH67814I0O) 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:58411-441-60 1 in 1 CARTON 06/01/2018 1 40 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 FINAL part352 06/01/2018 SHISEIDO SYNCHRO SKIN TINTED 3 MEDIUM
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-442 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1248 mg in 40 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2625 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TREHALOSE (UNII: B8WCK70T7I) ISODODECANE (UNII: A8289P68Y2) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) AGAR, UNSPECIFIED (UNII: 89T13OHQ2B) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ISOBUTANE (UNII: BXR49TP611) ISOPENTANE (UNII: ZH67814I0O) 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:58411-442-60 1 in 1 CARTON 06/01/2018 1 40 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 FINAL part352 06/01/2018 SHISEIDO SYNCHRO SKIN TINTED 4 MEDIUM DARK
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-443 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1248 mg in 40 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2625 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TREHALOSE (UNII: B8WCK70T7I) ISODODECANE (UNII: A8289P68Y2) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) AGAR, UNSPECIFIED (UNII: 89T13OHQ2B) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ISOBUTANE (UNII: BXR49TP611) ISOPENTANE (UNII: ZH67814I0O) 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:58411-443-60 1 in 1 CARTON 06/01/2018 1 40 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 FINAL part352 06/01/2018 SHISEIDO SYNCHRO SKIN TINTED 5 DARK
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-444 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1248 mg in 40 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2625 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TREHALOSE (UNII: B8WCK70T7I) ISODODECANE (UNII: A8289P68Y2) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) AGAR, UNSPECIFIED (UNII: 89T13OHQ2B) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ISOBUTANE (UNII: BXR49TP611) ISOPENTANE (UNII: ZH67814I0O) 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:58411-444-60 1 in 1 CARTON 06/01/2018 1 40 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 FINAL part352 06/01/2018 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-440, 58411-441, 58411-442, 58411-443, 58411-444) , ANALYSIS(58411-440, 58411-441, 58411-442, 58411-443, 58411-444)
