Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID aefd7884-6bc3-4b0b-ba36-1f3e8fe49f93
Route
TOPICAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Titanium Dioxide (32 mg)
Inactive Ingredients
Water Cyclomethicone 5 Phenyl Trimethicone Cyclomethicone 6 Butylene Glycol Propanediol Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Pentylene Glycol Polyglyceryl-4 Isostearate Corn Soybean Oil Carnauba Wax Iris X Germanica Nothovar. Florentina Root Ceramide Np Sorbitol Dimethicone Caffeine Peg/ppg-18/18 Dimethicone Peg-10 Dimethicone (600 Cst) Peg-30 Glyceryl Stearate Anileridine Cellulose Gum 2-oleamido-1,3-octadecanediol Perlite Aluminum Hydroxide Guanosine Magnesium Sulfate, Unspecified Form Cinnamic Acid Alcohol Poloxamer 188 Edetate Disodium Disodium Stearoyl Glutamate Hydroxypalmitoyl Sphinganine Caprylyl Glycol Lexidronam Pentasodium Bht Tocopherol Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Sorbic Acid Sodium Benzoate Phenoxyethanol Mica Bismuth Oxychloride Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-30 Until 2025-05-05

Description

Octinoxate 7.5% Titanium dioxide 3.2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5% Titanium dioxide 3.2%

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

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

Octinoxate 7.5%

Titanium dioxide 3.2%

Inactive Ingredients

water, cyclopentasiloxane, phenyl trimethicone, cyclohexasiloxane, butylene glycol, propanediol, cetyl PEG/PPG-10/1 dimethicone, pentylene glycol, polyglyceryl-4 isostearate, zea mays (corn) kernel extract, glycine soja (soybean) oil, copernicia cerifera (carnauba) wax, iris florentina root extract, ceramide NP, sorbitol, dimethicone, caffeine, PEG/PPG-18/18 dimethicone,PEG-10 dimethicone, PEG-30 glyceryl stearate, lecithin, silica silylate, cellulose gum, 2-oleamido-1,3-octadecanediol, perlite, aluminum hydroxide, guanosine, magnesium sulfate, alcohol denat., poloxamer 188, disodium EDTA, disodium stearoyl glutamate, hydrolyzed linseed extract, hydroxypalmitoyl sphinganine,caprylyl glycol, pentasodium ethylenediamine tetramethylene phosphonate, polycaprolactone, BHT, tocopherol, pentaerytrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, sodium benzoate, phenoxyethanol; may contain: mica, titanium dioxide, bismuth oxychloride, iron oxides

Questions Or Comments?

1-800-LANCOME (1-800-526-2663)

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

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, getmedical 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)

Octinoxate 7.5%

Titanium dioxide 3.2%

Inactive Ingredients (Inactive ingredients)

water, cyclopentasiloxane, phenyl trimethicone, cyclohexasiloxane, butylene glycol, propanediol, cetyl PEG/PPG-10/1 dimethicone, pentylene glycol, polyglyceryl-4 isostearate, zea mays (corn) kernel extract, glycine soja (soybean) oil, copernicia cerifera (carnauba) wax, iris florentina root extract, ceramide NP, sorbitol, dimethicone, caffeine, PEG/PPG-18/18 dimethicone,PEG-10 dimethicone, PEG-30 glyceryl stearate, lecithin, silica silylate, cellulose gum, 2-oleamido-1,3-octadecanediol, perlite, aluminum hydroxide, guanosine, magnesium sulfate, alcohol denat., poloxamer 188, disodium EDTA, disodium stearoyl glutamate, hydrolyzed linseed extract, hydroxypalmitoyl sphinganine,caprylyl glycol, pentasodium ethylenediamine tetramethylene phosphonate, polycaprolactone, BHT, tocopherol, pentaerytrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, sodium benzoate, phenoxyethanol; may contain: mica, titanium dioxide, bismuth oxychloride, iron oxides

Questions Or Comments? (Questions or comments?)

1-800-LANCOME (1-800-526-2663)

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

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, getmedical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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