Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID feabb713-4ef1-45b3-b34f-562e37b314d5
Route
TOPICAL
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg)
Inactive Ingredients
Water Cyclomethicone 6 Propylene Glycol Glycerin Octyldodecanol Stearic Acid Potassium Cetyl Phosphate Palmitic Acid Peg-100 Stearate Glyceryl Stearate Se Trolamine Phenoxyethanol Cetyl Alcohol Talc Dimethicone Silicon Dioxide Methylparaben Caprylyl Glycol Carboxypolymethylene Ethylparaben Capryloyl Salicylic Acid Xanthan Gum Edetate Disodium Anhydrous Butylphenyl Methylpropional .alpha.-hexylcinnamaldehyde Linalool, (+/-)- Sodium Palmitoyl Proline Limonene, (+/-)- Benzyl Salicylate Benzyl Alcohol .beta.-citronellol, (r)- Hydroxycitronellal Prunus Cerasus Flower Bud Rosa Centifolia Flower Nymphaea Alba Flower Mica Titanium Dioxide Bismuth Oxychloride Ferric Oxide Red Fd&c Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-07-31

Description

Octinoxate 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5%

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:

● shake well

● 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

Active Ingredient

Octinoxate 7.5%

Other Information

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

Inactive Ingredients

water, cyclohexasiloxane, propylene glycol, glycerin, octyldodecanol, stearic acid, potassium cetyl phosphate, palmitic acid, PEG-100 stearate, glyceryl stearate, triethanolamine, phenoxyethanol, cetyl alcohol, talc, dimethicone, silica, methylparaben, caprylyl glycol, carbomer, fragrance, ethylparaben, capryloyl salicylic acid, xanthan gum, disodium EDTA, butylphenyl methylpropional, hexyl cinnamal, linalool, sodium palmitoyl proline, limonene, benzyl salicylate, benzyl alcohol, citronellol, hydroxycitronellal, prunus cerasus (bitter cherry) extract, rosa centifolia flower extract, nymphaea alba flower extract; may contain: mica, titanium dioxide, bismuth oxychloride, iron oxides, red 4, yellow 5

Questions Or Comments?

1-800-944-0730

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:

● shake well

● 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

Active Ingredient (Active ingredient)

Octinoxate 7.5%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, cyclohexasiloxane, propylene glycol, glycerin, octyldodecanol, stearic acid, potassium cetyl phosphate, palmitic acid, PEG-100 stearate, glyceryl stearate, triethanolamine, phenoxyethanol, cetyl alcohol, talc, dimethicone, silica, methylparaben, caprylyl glycol, carbomer, fragrance, ethylparaben, capryloyl salicylic acid, xanthan gum, disodium EDTA, butylphenyl methylpropional, hexyl cinnamal, linalool, sodium palmitoyl proline, limonene, benzyl salicylate, benzyl alcohol, citronellol, hydroxycitronellal, prunus cerasus (bitter cherry) extract, rosa centifolia flower extract, nymphaea alba flower extract; may contain: mica, titanium dioxide, bismuth oxychloride, iron oxides, red 4, yellow 5

Questions Or Comments? (Questions or comments?)

1-800-944-0730

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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