Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 1b851e19-add0-437b-86e4-e88a10a1e774
Route
TOPICAL
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (68 mg)
Inactive Ingredients
Cyclomethicone 6 Water Dimethicone Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Propanediol Alcohol Butylene Glycol Phenyl Trimethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Magnesium Potassium Aluminosilicate Fluoride Polyglyceryl-4 Isostearate Phenoxyethanol Magnesium Sulfate, Unspecified Form Disodium Stearoyl Glutamate Peg/ppg-18/18 Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Aluminum Hydroxide Isobutane Benzyl Salicylate .alpha.-hexylcinnamaldehyde Benzyl Alcohol Butylated Hydroxytoluene Limonene, (+)- Linalool, (+/-)- Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Tocopherol Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01 Until 2026-06-01

Description

Octinoxate 6.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6.7%

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

Active Ingredient

Octinoxate 6.7%

Other Information

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

Flammable Until Dry.

Do not use near fire, flame, or heat.

Inactive Ingredients

cyclohexasiloxane, water, dimethicone, vinyl dimethicone/methicone silsesquioxane crosspolymer, propanediol, alcohol denat., butylene glycol, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, synthetic fluorphlogopite, polyglyceryl-4 isostearate, phenoxyethanol, magnesium sulfate, disodium stearoyl glutamate, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, PEG/PPG-18/18 dimethicone, fragrance, dimethicone/vinyl dimethicone crosspolymer, aluminum hydroxide, isobutene, benzyl salicylate, hexyl cinnamal, benzyl alcohol, BHT, limonene, linalool, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopherol, may contain: titanium dioxide, iron oxides

Questions Or Comments?

CONTACT: GIORGIO ARMANI PARFUMS

LUXURY PRODUCTS LLC

10 HUDSON YARDS, NEW YORK, NY 10001

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

Active Ingredient (Active ingredient)

Octinoxate 6.7%

Other Information (Other information)

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

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame, or heat.

Inactive Ingredients (Inactive ingredients)

cyclohexasiloxane, water, dimethicone, vinyl dimethicone/methicone silsesquioxane crosspolymer, propanediol, alcohol denat., butylene glycol, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, synthetic fluorphlogopite, polyglyceryl-4 isostearate, phenoxyethanol, magnesium sulfate, disodium stearoyl glutamate, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, PEG/PPG-18/18 dimethicone, fragrance, dimethicone/vinyl dimethicone crosspolymer, aluminum hydroxide, isobutene, benzyl salicylate, hexyl cinnamal, benzyl alcohol, BHT, limonene, linalool, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopherol, may contain: titanium dioxide, iron oxides

Questions Or Comments? (Questions or comments?)

CONTACT: GIORGIO ARMANI PARFUMS

LUXURY PRODUCTS LLC

10 HUDSON YARDS, NEW YORK, NY 10001

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.


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Raw Label Data

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