SPL v4
SPL
SPL Set ID 2633a289-b3b2-b614-e063-6294a90ad214
Route
TOPICAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octocrylene (80 mg) Octisalate (50 mg) Homosalate (100 mg)
Inactive Ingredients
Isopropyl Palmitate Benzyl Salicylate Linalool, (+/-)- Ceteareth-20 Water Cyclopentasiloxane Benzyl Alcohol Aloe Barbadensis Leaf Juice Saccharide Isomerate Mica Triethanolamine Sodium Stearoyl Glutamate Carbomer Ci 77891 White Wax Phenoxyethanol Citric Acid Sodium Citrate Cetearyl Alcohol Alpha-tocopherol Acetate Ci 77491 Hydroxyacetophenone Hexyl Cinnamal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

AVOBENZONE 3.0% HOMOSALATE 10% OCTISALATE 5.0% OCTOCRYLENE 8.0%


Medication Information

Description

AVOBENZONE 3.0% HOMOSALATE 10% OCTISALATE 5.0% OCTOCRYLENE 8.0%

Use

HELPS PREVENT SUNBURN

if used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

Directions for Sunscreen Use

apply liberally and evenly 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

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 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. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

Other information protect the product in this container from excessive heat and direct sun

Active Ingredients

AVOBENZONE 3.0%

HOMOSALATE 10%

OCTISALATE 5.0%

OCTOCRYLENE 8.0%

Inactive Ingredients

Water, Cera Alba, Cyclopentasiloxane, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Cyclohexasiloxane, Benzyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Hydroxyacetophenone, Saccharide Isomerate, Mica, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Carbomer, Fragrance, Citric Acid, Sodium Citrate, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Principal Display Panel

When Using This Product

Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children

If swallowed, get medical help or contac a Poison Control Center right away


Structured Label Content

Use (USE)

HELPS PREVENT SUNBURN

if used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

Directions for Sunscreen Use

apply liberally and evenly 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

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 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. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

Other information protect the product in this container from excessive heat and direct sun

Active Ingredients (ACTIVE INGREDIENTS)

AVOBENZONE 3.0%

HOMOSALATE 10%

OCTISALATE 5.0%

OCTOCRYLENE 8.0%

Inactive Ingredients

Water, Cera Alba, Cyclopentasiloxane, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Cyclohexasiloxane, Benzyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Hydroxyacetophenone, Saccharide Isomerate, Mica, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Carbomer, Fragrance, Citric Acid, Sodium Citrate, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Principal Display Panel

When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contac a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)