SEKKISEI TREATMENT BB 00- octinoxate, zinc oxide cream SEKKISEI TREATMENT BB 01- octinoxate, zinc oxide cream

SEKKISEI TREATMENT BB 01 by

Drug Labeling and Warnings

SEKKISEI TREATMENT BB 01 by is a Otc medication manufactured, distributed, or labeled by KOSE AMERICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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

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 Tube Label

BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

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 Tube Label

BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

INGREDIENTS AND APPEARANCE

SEKKISEI TREATMENT BB 00 
octinoxate, zinc oxide cream

Product 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: 657L0NC5MT)
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 cream

Product 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
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: 657L0NC5MT)
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: 66820-0201-1	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)