KOPARI SUNGLAZE SHEER BODY MIST SUNSCREEN SPF42- avobenzone, homosalate, octisalate, octocrylene spray

Kopari Sunglaze Sheer Body Mist Sunscreen SPF42 by

Drug Labeling and Warnings

Kopari Sunglaze Sheer Body Mist Sunscreen SPF42 by is a Otc medication manufactured, distributed, or labeled by Kopari Beauty, PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients 

Avobenzone 3 %
Homosalate 0.5 %
Octisalate 5%
Octocrylene 10%

Purpose

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 damaged or broken skin Do not spray in eyes.If contact occurs, rinse well with water. If irritation persists, consult a doctor.

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 dispensing. Spray directly onto skin. For Sunscreen use:Apply generously and evenly 15 minutes before sun exposure. Reapply
• After 80 minutes of swimming or sweating. Immediately after towel drying.
• At least every 2 hours

Sun Protection Measures:

Spending time in the sun increases your

risk of skin cancer & early skin aging. To decrease this risk, regularly use a

sunscreen with a Broad Spectrum SPF value of 15 or higher & 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 Ingredients

Alcohol Denat., C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Diisopropyl Adipate, Sodium Hyaluronate, Tocopherol, Hydrogenated Castor Oil, Tetrahexyldecyl Ascorbate, Ricinus Communis (Castor) Seed Oil, Dicaprylyl Carbonate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance (Parfum), Mica, T-Butyl Alcohol, Tin Oxide, Hexyl Cinnamal, Benzyl Salicylate, Linalool, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides).

Other Information

Protect the product in this container from excessive heat and direct sun

Questions/Comments

Call (858) 252-0099

Package Labeling:

INGREDIENTS AND APPEARANCE

KOPARI SUNGLAZE SHEER BODY MIST SUNSCREEN SPF42 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-000
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	5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CASTOR OIL (UNII: D5340Y2I9G)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
MICA (UNII: V8A1AW0880)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
STANNIC OXIDE (UNII: KM7N50LOS6)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-000-00	140 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/05/2024
2	NDC: 84130-000-20	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/05/2024

Labeler - Kopari Beauty (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(84130-000)