Label: SEKKISEI TREATMENT BB 00- octinoxate, zinc oxide cream
SEKKISEI TREATMENT BB 01- octinoxate, zinc oxide cream
- NDC Code(s): 66820-0200-1, 66820-0201-1
- Packager: KOSE AMERICA, INC.
- 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 July 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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 value 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
Inactive ingredients
WATER/AQUA/EAU · CYCLOMETHICONE · METHYL TRIMETHICONE · ALCOHOL · GLYCERIN · ETHYLHEXYL PALMITATE · DIISOSTEARYL MALATE · PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE · DISTEARDIMONIUM HECTORITE · TRIETHYLHEXANOIN · ALPINIA SPECIOSA LEAF EXTRACT · ANGELICA ACUTILOBA ROOT EXTRACT · CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT · COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT · MELOTHRIA HETEROPHYLLA ROOT EXTRACT · TOCOPHEROL · ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER · ALUMINUM HYDROXIDE · BHT · BUTYLENE GLYCOL · DIMETHICONE · DISODIUM STEAROYL GLUTAMATE · HYDROGEN DIMETHICONE · LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE · METHYL METHACRYLATE CROSSPOLYMER · PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE · PHYTOSTERYL/ISOSTERYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE · POLYISOPRENE · POLYPROPYLENE · SILICA · SODIUM CHLORIDE · STEARALKONIUM HECTORITE · TALC · TRIETHOXYCAPRYLYLSILANE · METHYLPARABEN · FRAGRANCE (PARFUM) · MAY CONTAIN (+/-): IRON OXIDES (CI 77491) · IRON OXIDES (CI 77492) · IRON OXIDES (CI 77499) · TITANIUM DIOXIDE (CI77891)
- Other information
- Principal Display Panel - 00 Carton Label
- Principal Display Panel - 00 Tube Label
- Principal Display Panel - 01 Carton Label
- Principal Display Panel - 01 Tube Label
-
INGREDIENTS AND APPEARANCE
SEKKISEI TREATMENT BB 00
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 83 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 66 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYL PALMITATE (UNII: 2865993309) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) SAFFLOWER (UNII: 4VBL71TY4Y) COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI) MELOTHRIA HETEROPHYLLA ROOT (UNII: RHN4J0C1KF) TOCOPHEROL (UNII: R0ZB2556P8) ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN) POLYISOPRENE (34000 MW) (UNII: 2HD3GI8VII) POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) TALC (UNII: 7SEV7J4R1U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYLPARABEN (UNII: A2I8C7HI9T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66820-0200-1 1 in 1 CARTON 03/01/2019 1 26 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 03/01/2019 SEKKISEI TREATMENT BB 01
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 83 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 66 mg in 1 mL Inactive Ingredients Ingredient Name Strength LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN) POLYISOPRENE (34000 MW) (UNII: 2HD3GI8VII) POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) TALC (UNII: 7SEV7J4R1U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYLPARABEN (UNII: A2I8C7HI9T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYL PALMITATE (UNII: 2865993309) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) SAFFLOWER (UNII: 4VBL71TY4Y) COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI) MELOTHRIA HETEROPHYLLA ROOT (UNII: RHN4J0C1KF) TOCOPHEROL (UNII: R0ZB2556P8) ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66820-0201-1 1 in 1 CARTON 03/01/2019 1 26 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 03/01/2019 Labeler - KOSE AMERICA, INC. (080407621)
