HERBAL UV DEFENSE SPF40- homosalate, octisalate, avobenzone, octocrylene gel

HERBAL UV DEFENSE SPF40 by

Drug Labeling and Warnings

HERBAL UV DEFENSE SPF40 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 9.5%

Octisalate 5%

Avobenzone 3.0%

Octocrylene 2.6%

PURPOSE

Purpose

Sunscreen

USES

Uses

• Helps prevent sunburn

WARNINGS

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

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours

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

Inactive Ingredients

Water, Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydroxyacetoph-enone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Limonene, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Glycine Soja (Soybean) Oil, Cellulose Gum, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-3 Diisostearate, Citrus Limon (Lemon) Peel Oil, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Lavandula Angustifolia (Lavender) Oil, Propanediol, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Citral, Centella Asiatica Extract

OTHER INFORMATION

Other information

Protect this product from excessive heat and direct sun

Packaging Label

INGREDIENTS AND APPEARANCE

HERBAL UV DEFENSE SPF40 
homosalate, octisalate, avobenzone, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BETAINE (UNII: 3SCV180C9W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BROCCOLI (UNII: UOI4FT57BZ)
TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BASIL OIL (UNII: Z129UMU8LE)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
PROPANEDIOL (UNII: 5965N8W85T)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-199-00	1 in 1 CARTON	01/03/2024
1		30 mg 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 - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-199)