Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 76e03a17-947a-492a-9e64-d3f7762de823
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 (50 mg) Octisalate (72 mg) Octocrylene
Inactive Ingredients
Water Glycerin Silicon Dioxide Dimethicone Niacinamide Alcohol Titanium Dioxide Peg-100 Stearate Glyceryl Monostearate Mica Tranexamic Acid Stearic Acid Phenoxyethanol Citric Acid Monohydrate Palmitic Acid Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Hydroxyacetophenone Dicaprylyl Carbonate Steareth-100 Phenylethyl Resorcinol Caprylyl Glycol Xanthan Gum Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Trisodium Ethylenediamine Disuccinate Tocopherol Hyaluronate Sodium Cymbopogon Schoenanthus Oil Citral Myristic Acid Ferric Oxide Red Stannic Oxide Geraniol Limonene, (+)- Linalool, (+/-)- .beta.-citronellol, (r)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-01

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7.2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7.2%

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

● 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 5%

Octisalate 5%

Octocrylene 7.2%

Inactive Ingredients

water, glycerin, silica, dimethicone, niacinamide, alcohol denat., titanium dioxide, PEG-100 stearate, glyceryl stearate, mica, tranexamic acid, stearic acid, phenoxyethanol, citric acid, palmitic acid, ammonium polyacryloyldimethyl taurate, hydroxyacetophenone, dicaprylyl carbonate, steareth-100, phenylethyl resorcinol, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, trisodium ethylenediamine disuccinate, synthetic fluorphlogopite, tocopherol, sodium hyaluronate, cymbopogon schoenanthus oil, citral, myristic acid, iron oxides, tin oxide, geraniol, limonene, linalool, citronellol

Questions Or Comments?

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

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

● 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 5%

Octisalate 5%

Octocrylene 7.2%

Inactive Ingredients (Inactive ingredients)

water, glycerin, silica, dimethicone, niacinamide, alcohol denat., titanium dioxide, PEG-100 stearate, glyceryl stearate, mica, tranexamic acid, stearic acid, phenoxyethanol, citric acid, palmitic acid, ammonium polyacryloyldimethyl taurate, hydroxyacetophenone, dicaprylyl carbonate, steareth-100, phenylethyl resorcinol, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, trisodium ethylenediamine disuccinate, synthetic fluorphlogopite, tocopherol, sodium hyaluronate, cymbopogon schoenanthus oil, citral, myristic acid, iron oxides, tin oxide, geraniol, limonene, linalool, citronellol

Questions Or Comments? (Questions or comments?)

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

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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