forever transfer-proof - 24h foundation high perfection concentrated floral skincare with sunscreen broad spectrum spf 15 2w

forever transfer-proof - 24h foundation high perfection concentrated floral skincare with sunscreen broad spectrum spf 15 2w
SPL v4
SPL
SPL Set ID 07f8282b-047b-4be1-8779-39ed5dd6fb5d
Route
topical
Published
Effective Date 2022-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (35 mg) titanium dioxide (37.6 mg)
Inactive Ingredients
water methyl trimethicone isododecane alcohol butylene glycol peg-9 polydimethylsiloxyethyl dimethicone silicon dioxide dimethicone 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) disteardimonium hectorite sodium myristoyl glutamate propylene carbonate chlorphenesin aluminum oxide stearic acid aluminum hydroxide tromethamine tocopherol tropaeolum majus flowering top rosa multiflora fruit 1,2-hexanediol caprylyl glycol iris x germanica nothovar. florentina root sodium benzoate potassium sorbate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-01-01 Until 2025-04-25

Purpose

Sunscreen

Description

Octinoxate 3.50 % Titanium Dioxide 3.76 %


Medication Information

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: ask a doctor.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

AQUA (WATER) • METHYL TRIMETHICONE • ISODODECANE • ALCOHOL • BUTYLENE GLYCOL • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • SYNTHETIC FLUORPHLOGOPITE • ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER • SILICA • DIMETHICONE • ACRYLATES/DIMETHICONE COPOLYMER • DISTEARDIMONIUM HECTORITE • POLYGLYCERYL-10 DECAISOSTEARATE • CETYL DIMETHICONE • SODIUM MYRISTOYL GLUTAMATE • PARFUM (FRAGRANCE) • PROPYLENE CARBONATE • CHLORPHENESIN • ALUMINA • STEARIC ACID • ALUMINUM HYDROXIDE • TROMETHAMINE • HYDROLYZED VIOLA TRICOLOR EXTRACT • TOCOPHEROL • TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT • ROSA MULTIFLORA FRUIT EXTRACT • 1,2-HEXANEDIOL • CAPRYLYL GLYCOL • IRIS FLORENTINA ROOT EXTRACT • SODIUM BENZOATE • POTASSIUM SORBATE. [MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)].

N° 15866/Z

Description

Octinoxate 3.50 % Titanium Dioxide 3.76 %

Do Not Use

on damaged or broken skin.

Drug Facts

Active Ingredients

Octinoxate 3.50 %

Titanium Dioxide 3.76 %

Package Labeling:20ml

Package Labeling:30ml

Package Labeling:2.7ml

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

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: ask a doctor.
Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

AQUA (WATER) • METHYL TRIMETHICONE • ISODODECANE • ALCOHOL • BUTYLENE GLYCOL • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • SYNTHETIC FLUORPHLOGOPITE • ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER • SILICA • DIMETHICONE • ACRYLATES/DIMETHICONE COPOLYMER • DISTEARDIMONIUM HECTORITE • POLYGLYCERYL-10 DECAISOSTEARATE • CETYL DIMETHICONE • SODIUM MYRISTOYL GLUTAMATE • PARFUM (FRAGRANCE) • PROPYLENE CARBONATE • CHLORPHENESIN • ALUMINA • STEARIC ACID • ALUMINUM HYDROXIDE • TROMETHAMINE • HYDROLYZED VIOLA TRICOLOR EXTRACT • TOCOPHEROL • TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT • ROSA MULTIFLORA FRUIT EXTRACT • 1,2-HEXANEDIOL • CAPRYLYL GLYCOL • IRIS FLORENTINA ROOT EXTRACT • SODIUM BENZOATE • POTASSIUM SORBATE. [MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)].

N° 15866/Z

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Active Ingredients (Active ingredients)

Octinoxate 3.50 %

Titanium Dioxide 3.76 %

Package Labeling:20ml

Package Labeling:30ml

Package Labeling:2.7ml

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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