Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c0c2aac2-1cd3-4e97-894c-a828fd9dba9b
Route
TOPICAL
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (70 mg)
Inactive Ingredients
Water Isododecane Isononyl Isononanoate Silicon Dioxide Carnauba Wax Glycerin Octyldodecanol Peg-30 Dipolyhydroxystearate Trolamine Polyamide-8 (4500 Mw) Phenoxyethanol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Octyldodecyl Xyloside Caprylyl Glycol Kaolin Edetate Disodium Sorbitan Isostearate Polysorbate 60 Linalool, (+/-)- Benzyl Salicylate Limonene, (+)- Benzyl Alcohol Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

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
Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 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

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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, isododecane, isononyl isononanoate, silica, copernicia cerifera (carnauba) wax, silica silylate, glycerin, octyldodecanol, PEG-30 dipolyhydroxystearate, triethanolamine, polyamide-8, phenoxyethanol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate, copolymer, octyldodecyl xyloside, caprylyl glycol, kaolin, disodium EDTA, sorbitan isostearate, polysorbate 60, linalool, benzyl salicylate, limonene, benzyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, fragrance

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 contact a Poison Control Center right away.


Structured Label Content

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
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 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)

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

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, isododecane, isononyl isononanoate, silica, copernicia cerifera (carnauba) wax, silica silylate, glycerin, octyldodecanol, PEG-30 dipolyhydroxystearate, triethanolamine, polyamide-8, phenoxyethanol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate, copolymer, octyldodecyl xyloside, caprylyl glycol, kaolin, disodium EDTA, sorbitan isostearate, polysorbate 60, linalool, benzyl salicylate, limonene, benzyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, fragrance

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 contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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