Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 066a0951-2e7e-40c0-8035-4d708a32f16c
Route
TOPICAL
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (67 mg) Titanium Dioxide (115 mg)
Inactive Ingredients
Water Dimethicone Isododecane Alcohol Trimethylsiloxysilicate (m/q 0.6-0.8) Butylene Glycol Peg-10 Dimethicone (600 Cst) Perlite Magnesium Potassium Aluminosilicate Fluoride Moringa Oleifera Seed Smallanthus Sonchifolius Root Juice Calcium Aluminum Borosilicate Glycerin Dipentaerythrityl Tetrahydroxystearate/tetraisostearate .alpha.-glucan Oligosaccharide Hyaluronate Sodium Silicon Dioxide Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Powdered Cellulose Aluminum Hydroxide Magnesium Sulfate, Unspecified Form Nylon-12 Sodium Phosphate, Dibasic, Anhydrous Disodium Stearoyl Glutamate Isopropyl Lauroyl Sarcosinate Hydrogen Dimethicone (13 Cst) Citric Acid Monohydrate Diisopropyl Sebacate Bis-peg/ppg-14/14 Dimethicone Emmental Lactobacillus Maltodextrin Disteardimonium Hectorite Butylated Hydroxytoluene Tocopherol Phenoxyethanol Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-12 Until 2026-12-28

Description

Octinoxate 6.7% Titanium dioxide 11.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6.7% Titanium dioxide 11.5%

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

Other Information

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

Active Ingredients



Octinoxate 6.7%

Titanium dioxide 11.5%

Flammable Until Dry.

Do not use near fire, flame, or heat.

Inactive Ingredients

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, moringa oleifera seed extract, polymnia sonchifolia root juice, calcium aluminum borosilicate, glycerin, dipentaerythrityl tetrahydroxystearate/tetraisostearate, alpha-glucan oligosaccharide, sodium hyaluronate, silica, silica silylate, HDI/trimethylol hexyllactone crosspolymer, cellulose, aluminum hydroxide, magnesium sulfate, nylon-12, disodium phosphate, disodium stearoyl glutamate, isopropyl lauroyl sarcosinate, hydrogen dimethicone, citric acid, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone, lactobacillus, maltodextrin, disteardimonium hectorite, BHT, tocopherol, phenoxyethanol; may contain: titanium dioxide, iron oxides, chromium oxide greens

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 wate 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

Other Information (Other information)

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

Active Ingredients (Active ingredients)



Octinoxate 6.7%

Titanium dioxide 11.5%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame, or heat.

Inactive Ingredients (Inactive ingredients)

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, moringa oleifera seed extract, polymnia sonchifolia root juice, calcium aluminum borosilicate, glycerin, dipentaerythrityl tetrahydroxystearate/tetraisostearate, alpha-glucan oligosaccharide, sodium hyaluronate, silica, silica silylate, HDI/trimethylol hexyllactone crosspolymer, cellulose, aluminum hydroxide, magnesium sulfate, nylon-12, disodium phosphate, disodium stearoyl glutamate, isopropyl lauroyl sarcosinate, hydrogen dimethicone, citric acid, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone, lactobacillus, maltodextrin, disteardimonium hectorite, BHT, tocopherol, phenoxyethanol; may contain: titanium dioxide, iron oxides, chromium oxide greens

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 wate 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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