Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID defa9588-95be-4f5c-86bb-53d6a1df7f5f
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (27 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Glyceryl Stearate Se Glycerin Pentylene Glycol Ceramide Np Ceramide Ap Ceramide 1 Phytosphingosine Sodium Lauroyl Lactylate Cholesterol Xanthan Gum Carboxypolymethylene Hydroxyacetophenone Edetate Disodium Citric Acid Monohydrate Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-22

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.7%

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 hear and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.7%

Inactive Ingredient

water, C12-15 alkyl benzoate, glyceryl stearate SE, methyl methacrylate crosspolymer, glycerin, pentylene glycol, ceramide NP (ceramide 3), ceramide AP (ceramide 6-II), ceramide EOP (ceramide 1), phytosphingosine, sodium acryloyldimethyltaurate/VP crosspolymer, sodium lauroyl lactylate, cholesterol, xanthan gum, carbomer, hydroxyacetophenone, disodium EDTA, citric acid, sodium hyaluronate

Questions Or Comments?

Toll-free number 1-888-768-2915

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

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

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.7%

Inactive Ingredient (Inactive ingredient)

water, C12-15 alkyl benzoate, glyceryl stearate SE, methyl methacrylate crosspolymer, glycerin, pentylene glycol, ceramide NP (ceramide 3), ceramide AP (ceramide 6-II), ceramide EOP (ceramide 1), phytosphingosine, sodium acryloyldimethyltaurate/VP crosspolymer, sodium lauroyl lactylate, cholesterol, xanthan gum, carbomer, hydroxyacetophenone, disodium EDTA, citric acid, sodium hyaluronate

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

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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