Lumasol: Package Insert and Label Information

LUMASOL- homosalate, octisalate, avobenzone and octocrylene spray
Luma Suncare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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? Call # (317) 586-2765

Packaging for inner glass

First image of outer packaging

Second image of outer packaging

Inner 10 mL vial packageLumasol Outer Packaging Part 1Lumasol Outer Packaging Part 2

LUMASOL avobenzone, homosalate, octisalate, octocrylene spray

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (HOMOSALATE) HOMOSALATE 15 g in 100 g OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g

Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 .ALPHA.-TOCOPHEROL ACETATE GRAPEFRUIT OIL DIISOPROPYL ADIPATE ALKYL (C12-15) BENZOATE ISODODECANE ALCOHOL DICAPRYLYL ETHER BUTYLOCTYL SALICYLATE GLYCERIN 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73578-288-10 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY 1 10 g in 1 BOTTLE, SPRAY This package is contained within the CARTON (73578-288-10) 2 NDC:73578-288-30 3 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY 2 10 g in 1 BOTTLE, SPRAY This package is contained within the CARTON (73578-288-30)

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)

Revised: 03/2020 Luma Suncare, Inc.