SEKKISEI HERBAL UV DEFENSE GEL- avobenzone, homosalate, octisalate, and octocrylene gel

SEKKISEI HERBAL UV DEFENSE gel by

Drug Labeling and Warnings

SEKKISEI HERBAL UV DEFENSE gel by is a Otc medication manufactured, distributed, or labeled by KOSE AMERICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Avobenzone 3.0%

Homosalate 9.5%

Octisalate 5.0%

Octocrylene 2.6%

PURPOSE

Sunscreen

USES

• Helps Prevent Sunburn.

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 USE

Do not useon damaged or broken skin.

WHEN USING

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

STOP USE

Stop use and ask a doctorif rash occurs.

KEEP OUT OF REACH OF CHILDREN

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.

INGREDIENTS AND APPEARANCE

SEKKISEI HERBAL UV DEFENSE GEL 
avobenzone, homosalate, octisalate, and octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66820-0400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	95 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66820-0400-1	1 in 1 CARTON	01/03/2024
1		30 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 Drug	M020	01/03/2024

Labeler - KOSE AMERICA, INC. (080407621)