Label: SEKKISEI HERBAL UV DEFENSE GEL- avobenzone, homosalate, octisalate, and octocrylene gel
- NDC Code(s): 66820-0400-1
- Packager: KOSE AMERICA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 15, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- PRINCIPAL DISPLAY PANEL - 30 mL Tube
-
INGREDIENTS AND APPEARANCE
SEKKISEI HERBAL UV DEFENSE GEL
avobenzone, homosalate, octisalate, and octocrylene gelProduct 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)
