Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 6ca01ccb-07f8-4d2c-84bb-6b251e73dad2
Route
TOPICAL
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (73 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Water Isododecane Silicon Dioxide Butyloctyl Salicylate Alkyl (c12-15) Benzoate Carnauba Wax Niacinamide Glycerin Octyldodecanol Peg-30 Dipolyhydroxystearate Polyamide-8 (4500 Mw) Phenoxyethanol Diethylhexyl Syringylidenemalonate Octyldodecyl Xyloside Hydroxyacetophenone Caprylyl Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Trisodium Ethylenediamine Disuccinate Medium-chain Triglycerides Coconut Juice Sorbitan Isostearate Polysorbate 60 Citric Acid Monohydrate Hyaluronate Sodium Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Sodium Benzoate Ethylhexylglycerin Potassium Sorbate

Identifiers & Packaging

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

Description

Avobenzone 3% Homosalate 7.3% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 7.3% Octisalate 5% Octocrylene 10%

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 7.3%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

water, isododecane, silica, butyloctyl salicylate, c12-15 alkyl benzoate, copernicia cerifera (carnauba) wax, niacinamide, glycerin, octyldodecanol, PEG-30 dipolyhydroxystearate, silica silylate, polyamide-8, phenoxyethanol, diethylhexyl syringylidenemalonate, octyldodecyl xyloside, hydroxyacetophenone, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, cocos nucifera (coconut) fruit juice, fragrance, sorbitan isostearate, polysorbate 60, citric acid, sodium hyaluronate, hydrolyzed opuntia ficus-indica flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium benzoate, ethylhexylglycerin, potassium sorbate

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 7.3%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

water, isododecane, silica, butyloctyl salicylate, c12-15 alkyl benzoate, copernicia cerifera (carnauba) wax, niacinamide, glycerin, octyldodecanol, PEG-30 dipolyhydroxystearate, silica silylate, polyamide-8, phenoxyethanol, diethylhexyl syringylidenemalonate, octyldodecyl xyloside, hydroxyacetophenone, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, cocos nucifera (coconut) fruit juice, fragrance, sorbitan isostearate, polysorbate 60, citric acid, sodium hyaluronate, hydrolyzed opuntia ficus-indica flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium benzoate, ethylhexylglycerin, potassium sorbate

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.


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