Active ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Octocrylene 2.6%

Purpose

Sunscreen

Uses

Helps prevent sunburn
If used as directed with other Sun Protection Measures (see Directions) decrease the risk of skin cancer and early skin aging damaged by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When you use this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

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

Directions

Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
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 of age: Ask a doctor

Other information

Protect this product from excessive heat and direct sun

Inactive Ingredients:

Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate

Secondary

INVISIBLE SUNSCREEN SPF 40
homosalate, octisalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:84426-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 mg in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
ISOMALT (UNII: S870P55O2W)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TOCOPHEROL (UNII: R0ZB2556P8)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
SESAME SEED (UNII: 7Y1255HVXR)
VITIS VINIFERA FRUIT RIND (UNII: 653OHN32Q1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:84426-001-01	1 in 1 CARTON	06/28/2024
1		50 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/28/2024

Labeler - PARTICLE AESTHETIC SCIENCE LTD (521782995)

Name	Address	ID/FEI	Business Operations
Establishment
COSMAX USA		010990210	manufacture(84426-001)

PARTICLE FOR MEN INVISIBLE SUNSCREEN SPF 40

Directions

Other information