SEKKISEI HERBAL UV DEFENSE GEL- avobenzone, homosalate, octisalate, and octocrylene gel 
KOSE AMERICA, INC.

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SEKKISEI HERBAL UV DEFENSE GEL BROAD SPECTRUM SPF 40 SUNSCREEN

Drug Facts

ACTIVE INGREDIENT

Avobenzone 3.0%

Homosalate 9.5%

Octisalate 5.0%

Octocrylene 2.6%

PURPOSE

Sunscreen

USES

TO USE:Apply evenly over face and body before sun exposure. Also works as an excellent makeup base.

WARNINGS

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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 INGREDIENT

Water (AQUA), Butyloctyl Salicylate, Dipropylene Glycol, Caprylyl Methicone, Methyl Trimethicone, Betaine, Silica, Aloe Barbadensis Leaf Extract, Bioflavonoids, Brassica Oleracea Italica (Broccoli) Extract, Caesalpinia Spinosa Fruit Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Coix Lacryma-Jobi MA-YUEN Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Kappaphycus Alvarezii Extract, Lavandula Angustifolia (Lavender) Oil, Tocopheryl Acetate, Tropaeolum Majus Flower/Leaf/Stem Extract, 1,2-Hexanediol, Aminomethyl Propanol, Ammonium Acryloyldimethyltaura TE/VP Copolymer, Angelica Gigas Root Extract, Biosaccharide Gum-4, Butylene Glycol, Carbomer, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydroxyacetophenone, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Propanediol, Phenoxyethanol, Potassium Sorbate

Other information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 mL Tube

SEKKISEI HERBAL UV DEFENSE GEL

Broad Spectrum SPF 40 Sunscreen

KOSE

e 30 mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 ml Tube

SEKKISEI HERBAL UV DEFENSE GEL 
avobenzone, homosalate, octisalate, and octocrylene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66820-0400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE95 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
BETAINE (UNII: 3SCV180C9W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
BROCCOLI (UNII: UOI4FT57BZ)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)  
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
BASIL OIL (UNII: Z129UMU8LE)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
PROPANEDIOL (UNII: 5965N8W85T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66820-0400-11 in 1 CARTON01/03/2024
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/03/2024
Labeler - KOSE AMERICA, INC. (080407621)

Revised: 3/2024
Document Id: 139b81df-d098-e7b0-e063-6294a90ab29a
Set id: cb0faa3a-68f8-49c5-8c28-3338b1b27cd8
Version: 2
Effective Time: 20240315
 
KOSE AMERICA, INC.