SUN PROTECTION SPF 50- avobenzone 2.9%, homosalate 4.0%, octisalate 4.9%, octocrylene 9.5% spray

Sun Protection SPF 50 by

Drug Labeling and Warnings

Sun Protection SPF 50 by is a Otc medication manufactured, distributed, or labeled by Skinresource.md, L.L.C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Avobenzone - 2.9% - Homosalate - 4.0% - Octisalate - 4.9% - Octocrylene - 9.5%

INACTIVE INGREDIENT

Inactive Ingredients:

Acrylates/Octylacrylamide Copolymer, Alcohol Denat, Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Ethyl Ferulate, Helianthus Annuus (Sunflower)

Seed Oil*, Polyester-8, Tocopherol.

* Indicates Certified Organic Ingredient.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

if product is swallowed, get medical help or contact a Poison Control Center right away

WARNINGS

Warnings

For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.

Protect this product from excessive heat and direct sun

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 skin irritation or redness occurs for more than 72 hours.

PURPOSE

DOSAGE & ADMINISTRATION

Directions Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day or after swimming or sweating. Children under 6 months: ask a doctor.

Sun Protection Measure: 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.

to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

INDICATIONS & USAGE

Uses Helps prevent sunburn If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.

Protect this product from excessive heat and direct sun

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 skin irritation or redness occurs for more than 72 hours.

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. Reapply: Every 2 hours during the day after swimming or sweating. Children under 6 months: ask a doctor.

Sun Protection Measure: 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.

to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN PROTECTION SPF 50 
avobenzone 2.9%, homosalate 4.0%, octisalate 4.9%, octocrylene 9.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83694-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.08 g  in 177 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	16.815 g  in 177 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	8.673 g  in 177 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	5.133 g  in 177 g

Inactive Ingredients
Ingredient Name	Strength
ETHYL FERULATE (UNII: 5B8915UELW)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TOCOPHEROL (UNII: R0ZB2556P8)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83694-011-01	177 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2025

Labeler - Skinresource.md, L.L.C. (022050636)