gr

gr
SPL v2
SPL
SPL Set ID 038ec45a-0d56-4cd9-8060-767b382c1237
Route
topical
Published
Effective Date 2022-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (1 g)
Inactive Ingredients
water cyclomethicone 5 dimethicone, unspecified peg-10 dimethicone (600 cst) phenyl trimethicone peg-9 polydimethylsiloxyethyl dimethicone polymethylsilsesquioxane/trimethylsiloxysilicate caprylyl trisiloxane trimethylsiloxysilicate (m/q 0.6-0.8) propylene glycol silica dimethyl silylate disteardimonium hectorite dimethicone/vinyl dimethicone crosspolymer (soft particle) propylsilsesquioxane, hydrogen terminated sodium chloride zinc pidolate phenoxyethanol silicon dioxide dimethicone crosspolymer (450000 mpa.s) peg-12 dimethicone/ppg-20 crosspolymer .alpha.-tocopherol acetate peg/ppg-18/18 dimethicone talc isododecane xanthan gum triethoxycaprylylsilane titanium dioxide ethylhexylglycerin edetate disodium anhydrous isoceteth-10 magnesium stearate aluminum hydroxide linalool, (+/-)- ferric oxide red ferric oxide yellow ferrosoferric oxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-07-22 Until 2029-07-31

Purpose

Sunscreen

Description

Octinoxate 1% w/v


Medication Information

Warnings

For external use only

Do not use  • on damaged or broken skin When using this product    • keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if  • rash occurs

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

Purpose

Sunscreen

Directions

• apply generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • 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 sun Broad Spectrum SPF value of 15 or higher and other 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

Other Information

• protect the product in this container from excessive heat and direct sun. • store at room temperatures: 15°C- 30°C.

Inactive Ingredients

Water (Aqua), Cyclopentasiloxane, Dimethicone, Peg-10 Dimethicone, Phenyl Trimethicone, Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Caprylyl Methicone, Trımethylsiloxysilicate, Propylene Glycol, Silica Dimethyl Silylate, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Polypropylsılsesquioxane, Sodıum Chloride, Zinc Pca, Phenoxyethanol, Silica, Dimethicone Crosspolymer, Peg-12 Dimethicone/Ppg-20 Crosspolymer, Tocopheryl Acetate, Peg/Ppg-18/18 Dimethicone, Talc, Isododecane, Xanthan Gum, Triethoxycaprylylsilane, Titanium Dioxide, Ethylhexylglycerın, Disodium Edta, Isoceteth-10, Fragrance, Magnesium Stearate, Aluminum Hydroxide, Linalool. * Iron Oxides. *contains one or more of these ingredients.

Description

Octinoxate 1% w/v

Section 42229-5

SPF 15

Vitamin E

01 PORCELAIN

•Full Coverage & Longwear

•Semi-Matte & Smooth Finish

•Lightweight/Non-Oily Formula

DERMATOLOGICALLY TESTED

ERKUL KOZMETIK San. Tic. A.Ş.,

P.Ofisi Cd. No:1 Avcılar, IST./TURKEY

MADE IN TURKEY

EU R.P: Platin Beauty Consulting UG

(haftungsbeschränkt)

Bardowicker Str. 6,

21335 Lüneburg/GERMANY

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredients

Octinoxate 1% w/v


Structured Label Content

Warnings

For external use only

Do not use  • on damaged or broken skin When using this product    • keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if  • rash occurs

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

Purpose

Sunscreen

Directions

• apply generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • 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 sun Broad Spectrum SPF value of 15 or higher and other 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

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun. • store at room temperatures: 15°C- 30°C.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cyclopentasiloxane, Dimethicone, Peg-10 Dimethicone, Phenyl Trimethicone, Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Caprylyl Methicone, Trımethylsiloxysilicate, Propylene Glycol, Silica Dimethyl Silylate, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Polypropylsılsesquioxane, Sodıum Chloride, Zinc Pca, Phenoxyethanol, Silica, Dimethicone Crosspolymer, Peg-12 Dimethicone/Ppg-20 Crosspolymer, Tocopheryl Acetate, Peg/Ppg-18/18 Dimethicone, Talc, Isododecane, Xanthan Gum, Triethoxycaprylylsilane, Titanium Dioxide, Ethylhexylglycerın, Disodium Edta, Isoceteth-10, Fragrance, Magnesium Stearate, Aluminum Hydroxide, Linalool. * Iron Oxides. *contains one or more of these ingredients.

Section 42229-5 (42229-5)

SPF 15

Vitamin E

01 PORCELAIN

•Full Coverage & Longwear

•Semi-Matte & Smooth Finish

•Lightweight/Non-Oily Formula

DERMATOLOGICALLY TESTED

ERKUL KOZMETIK San. Tic. A.Ş.,

P.Ofisi Cd. No:1 Avcılar, IST./TURKEY

MADE IN TURKEY

EU R.P: Platin Beauty Consulting UG

(haftungsbeschränkt)

Bardowicker Str. 6,

21335 Lüneburg/GERMANY

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredients (Active ingredients)

Octinoxate 1% w/v


Advanced Ingredient Data


Raw Label Data

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