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

Inner 10 mL vial package

First image of outer packaging

Lumasol Outer Packaging Part 1

Second image of outer packaging

Lumasol Outer Packaging Part 2Inner 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.

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