Sun Protection SPF 50

Manufacturer
Skinresource.md, L.L.C.
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:05:47

Label at a glance#

ProductSun Protection SPF 50
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Active Ingredient

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

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive IngredientsInactive 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of childrenKeep out of reach of children:

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

WARNINGS SECTION

WarningsWarningsWarnings

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.

OTC - PURPOSE SECTION

PurposePurpose

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and 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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83694-011-01Sun Protection SPF 50177 g in 1 BOTTLE, SPRAYSPRAY1773

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83694-01183694-011-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Protection SPF 50AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5%Skinresource.md, L.L.C.2a0c3dd1-4bc0-6664-e063-6294a90af4b32025-06-25WarningsExact identifier
ndc (package): 83694-011-01
ndc (product): 83694-011
ndc11 (package): 83694001101
spl id: 386fedd0-893e-f833-e063-6294a90a41b1
spl set id: 2a0c3dd1-4bc0-6664-e063-6294a90af4b3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.