SEKKISEI TREATMENT BB 00- octinoxate, zinc oxide cream 
SEKKISEI TREATMENT BB 01- octinoxate, zinc oxide cream 
KOSE AMERICA, INC.

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.

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Drug Facts

Active Ingredients

OCTINOXATE 7.4%

ZINC OXIDE 5.9%

Purpose

Sunscreen

Sunscreen

Use

helps prevent sunburn

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:

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

Protect this product from excessive heat and direct sun

Principal Display Panel - 00 Carton Label

BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

e 26 mL NET WT. 1 OZ.

Principal Display Panel - 00 Carton Label

Principal Display Panel - 00 Tube Label

BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

Principal Display Panel - 00 Tube Label

Principal Display Panel - 01 Carton Label

BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

e 26 mL NET WT. 1 OZ.

Principal Display Panel - 01 Carton Label

Principal Display Panel - 01 Tube Label

BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

Principal Display Panel - 01 Tube Label
SEKKISEI TREATMENT BB 00 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66820-0200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE83 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE66 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66820-0200-11 in 1 CARTON03/01/2019
126 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2019
SEKKISEI TREATMENT BB 01 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66820-0201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE83 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE66 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66820-0201-11 in 1 CARTON03/01/2019
126 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2019
Labeler - KOSE AMERICA, INC. (080407621)

Revised: 7/2023
Document Id: 00efdae6-3753-95c0-e063-6394a90a4a94
Set id: 05a6e307-dec0-4751-bf3c-db456828a168
Version: 4
Effective Time: 20230720
 
KOSE AMERICA, INC.