SUNGLAZE SHEER SETTING MIST SUNSCREEN SPF50- avobenzone, homosalate, octisalate, octyocrylene spray

Sunglaze Sheer Setting Mist Sunscreen SPF50 by

Drug Labeling and Warnings

Sunglaze Sheer Setting Mist Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%, Homosalate 0.5%, Octisalate 5%, Octyocrylene 10%

Purpose

Avobenzone 3%, Homosalate 0.5%, Octisalate 5%, Octyocrylene 10%.................Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

Warnings

For external use only

● Do not use on damage or broken skin

● When using this product keep out of eyes. Rinse with water to remove.

● Stop use and ask a doctor if a rash occurs.

● Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake well before use. With eyes closed, spray generously and evenlyover your face while holding spray 8-10 inches away. Apply 15 minutesbefore sun exposure. Reapply: After 40 minutes of swimming orsweating. Immediately after towel drying. At least every 2 hours. Do notspray directly into eyes Sun Protection Measures Spending time in thesun increases your risk of skin cancer & early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 orhigher & other sun protection measures including: Limit time in the sun,especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, hats, andsunglasses Children under 6 months of age: Ask a doctor

Inactive Ingredients

Alcohol Denat., Butyloctyl Salicylate, Diisopropyl Adipate, Lauryl Lactate, Dicaprylyl Carbonate, Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer, Tetrahexyldecyl Ascorbate, Tocopherol, Citrus Aurantifolia (Lime) Oil, Litsea Cubeba Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Viridis (Spearmint) Leaf Oil, Citrus Aurantium Peel Oil, Hydrogenated Castor Oil, Oryza Sativa (Rice) Bran Extract, Communis (Castor) Seed Oil, Glycerin, Triethyl Citrate, Gamma Decalactone, Maltol, Dimethyl Heptenal, Hexyl Acetate, Ethyl Butyrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, t-Butyl Alcohol, Mica, Water/Aqua/Eau, Propanediol, Polyglutamic Acid, Citric Acid, Sodium Benzoate, Limonene, Geraniol, Geranyl Acetate, Terpineol, 3,6-Nonadienol, Tin Oxide, CI 77891 (Titanium DIoxide), CI 77491 (Iron Oxides).

Other Information

Protect this product fromexcessive heat and direct sun

May stain some fabrics

Questions/Comments

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Kopari

Sunglaze

Sheer Setting Mist

Sunscreen SPF 50

Broad Spectrum UVA-UVB

40-Minute Sweat &

Water Resistant

2.53 Fl. Oz. | 75 mL

INGREDIENTS AND APPEARANCE

SUNGLAZE SHEER SETTING MIST SUNSCREEN SPF50 
avobenzone, homosalate, octisalate, octyocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LAURYL LACTATE (UNII: G5SU0BFK7O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
MALTOL (UNII: 3A9RD92BS4)
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
GLYCERIN (UNII: PDC6A3C0OX)
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
GERANIOL (UNII: L837108USY)
TOCOPHEROL (UNII: R0ZB2556P8)
RICE BRAN (UNII: R60QEP13IC)
CASTOR OIL (UNII: D5340Y2I9G)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
MICA (UNII: V8A1AW0880)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GERANYL ACETATE (UNII: 3W81YG7P9R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
WATER (UNII: 059QF0KO0R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TERPINEOL (UNII: R53Q4ZWC99)
ALCOHOL (UNII: 3K9958V90M)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
LITSEA OIL (UNII: 2XIW34BN6O)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
HEXYL ACETATE (UNII: 7U7KU3MWT0)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
SPEARMINT OIL (UNII: C3M81465G5)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-011-25	75 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/23/2024
2	NDC: 84130-011-13	40 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/23/2024

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(84130-011)