LUMASOL- avobenzone, homosalate, octisalate, octocrylene spray

Lumasol by

Drug Labeling and Warnings

Lumasol by is a Otc medication manufactured, distributed, or labeled by Luma Suncare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%, Homosalate 15%, 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 and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

FLAMMABLE. Do not spray on an open flame or other ignition source. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

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

Directions

* Apply liberally 15 minutes before sun exposure
* Use a water resistant sunscreen if swimming or sweating
* 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 and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
* Limit time in the sun, especially from 10 a.m. to 2 p.m.
* Wear long sleeve shirts, pants, hats and sunglasses

Other Information

* Do not expose to temperatures exceeding 100 °F/40 °C.

Inactive Ingredients

Alcohol Denat., C28-52 Olefin/Undecylenic Acid Copolymer, Isododecane, Dicaprylyl Ether, Cyclopentasiloxane, Diisopropyl Adipate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Glycerin, Tocopheryl Acetate, Citrus Paradisi (Grapefruit) Peel Oil, Silica Silylate, Menthoxypropanediol

QUESTIONS

Questions? Call # (317) 586-2765

PRINCIPAL DISPLAY PANEL

Packaging for inner glass

First image of outer packaging

Second image of outer packaging

INGREDIENTS AND APPEARANCE

LUMASOL 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73578-288
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPEFRUIT OIL (UNII: YR377U58W9)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73578-288-10	1 in 1 CARTON	04/03/2020
1		10 g in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package
2	NDC: 73578-288-30	3 in 1 CARTON	04/03/2020
2		10 g in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/03/2020

Labeler - Luma Suncare, Inc. (117363673)