Gr 

Gr 
SPL v2
SPL
SPL Set ID 751d5194-f5ea-401b-9439-7770510a588c
Route
TOPICAL
Published
Effective Date 2022-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (6 g) Oxybenzone (2 g)
Inactive Ingredients
Water Dimethicone, Unspecified Polymethylsilsesquioxane (4.5 Microns) Butylene Glycol Squalane Peg-40 Monostearate Docosanol Glyceryl Monostearate Talc Phenyl Trimethicone Polyglyceryl-10 Pentastearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Phenoxyethanol .alpha.-tocopherol Acetate Titanium Dioxide Sodium Stearoyl Lactylate Glycerin Pentylene Glycol Strelitzia Nicolai Whole Sodium Dehydroacetate Luviset 360 Polysorbate 60 Isopropyl Titanium Triisostearate Citric Acid Monohydrate Fructose Sodium Hydroxide Urea Ethylhexylglycerin Tromethamine Magnesium Stearate Sorbitan Isostearate Allantoin Maltose, Unspecified Form Sodium Chloride Sodium Lactate Sodium Pyrrolidone Carboxylate Trehalose Aluminum Hydroxide Sodium Laureth-12 Sulfate Caprylyl Glycol Anhydrous Dextrose Hyaluronate Sodium C11-15 Pareth-7 Potassium Sorbate Mica Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Fd&c Yellow No. 5 Fd&c Blue No. 1 Chromic Oxide Ultramarine Blue

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-07-22 Until 2028-05-31

Description

Octinoxate 6% w/v Oxybenzone 2% w/v

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6% w/v Oxybenzone 2% w/v

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 42229-5

GOLDEN ROSE

COLOR CORRECTING PRIMER

Correct • Brighten • Protect

Green correcting shade neutralises redness tone for a flawless make-up.

Orange correcting shade neutralises the look of dark circles & brown spots on medium to deep skin tones for a flawless make-up.

Violet correcting shade neutralises dull yellow undertones on light to medium skin tones for a flawless make-up.

Yellow correcting shade neutralises purple/blue tones corrects mild redness tone for a flawless make-up.

• Smooths, evens and brightens skin tone, hide dullness and dark spots.

• Contains skin friendly pure moisturiser complex.

• With SPF 30 to protect your skin against the harmful sunrays. Apply to cleaned skin. Can be used alone or under foundation.

DERMATOLOGICALLY TESTED

Manufactured By:

ERKUL COSMETICS San. Tic. A.Ş.,

Petrol Ofisi Cad. No:1

Avcılar, Istanbul, Turkey, 34310

Phone: +90 212 456 53 00

www.goldenrose.com.tr

[email protected]

MADE IN TURKEY

Distributed By:

CELESTY LLC

3970 NW 167TH ST.

MIAMI GARDENS,

FL 33054 – USA

[email protected]

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.

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

Packaging

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

Drug Facts

Other Information

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

Active Ingredients

Octinoxate 6% w/v

Oxybenzone 2% w/v

Inactive Ingredients

Water(Aqua), Dimethicone, Polymethylsilsesquioxane, Butylene Glycol, Squalane, Peg-40 Stearate, Behenyl Alcohol, Glyceryl Stearate, Talc, Phenyl Trimethicone, Polyglyceryl-10 Pentastearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Tocopheryl Acetate, Titanium Dioxide, Sodium Stearoyl Lactylate, Glycerin, Pentylene Glycol, Strelitzia Nicolai Seed Aril Extract, Sodium Dehydroacetate, Acrylates Copolymer, Polysorbate 60, Isopropyl Titanium Triisostearate, Citric Acid, Fructose, Sodium Hydroxide, Urea, Ethylhexylglycerin, Tromethamine, Magnesium Stearate, Sorbitan Isostearate, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium Pca, Trehalose, Aluminum Hydroxide, Sodium Laureth-12 Sulfate, Caprylyl Glycol, Glucose, Sodium Hyaluronate, C11-15 Pareth-7, Potassium Sorbate. *Mica, *Iron oxides, *Yellow 5, * Blue 1, *Chromium Oxide Greens, Ultramarine.

*contains one or more of these ingredients.


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 42229-5 (42229-5)

GOLDEN ROSE

COLOR CORRECTING PRIMER

Correct • Brighten • Protect

Green correcting shade neutralises redness tone for a flawless make-up.

Orange correcting shade neutralises the look of dark circles & brown spots on medium to deep skin tones for a flawless make-up.

Violet correcting shade neutralises dull yellow undertones on light to medium skin tones for a flawless make-up.

Yellow correcting shade neutralises purple/blue tones corrects mild redness tone for a flawless make-up.

• Smooths, evens and brightens skin tone, hide dullness and dark spots.

• Contains skin friendly pure moisturiser complex.

• With SPF 30 to protect your skin against the harmful sunrays. Apply to cleaned skin. Can be used alone or under foundation.

DERMATOLOGICALLY TESTED

Manufactured By:

ERKUL COSMETICS San. Tic. A.Ş.,

Petrol Ofisi Cad. No:1

Avcılar, Istanbul, Turkey, 34310

Phone: +90 212 456 53 00

www.goldenrose.com.tr

[email protected]

MADE IN TURKEY

Distributed By:

CELESTY LLC

3970 NW 167TH ST.

MIAMI GARDENS,

FL 33054 – USA

[email protected]

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.

Purpose

Sunscreen

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

Packaging

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

Drug Facts

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Octinoxate 6% w/v

Oxybenzone 2% w/v

Inactive Ingredients (Inactive ingredients)

Water(Aqua), Dimethicone, Polymethylsilsesquioxane, Butylene Glycol, Squalane, Peg-40 Stearate, Behenyl Alcohol, Glyceryl Stearate, Talc, Phenyl Trimethicone, Polyglyceryl-10 Pentastearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Tocopheryl Acetate, Titanium Dioxide, Sodium Stearoyl Lactylate, Glycerin, Pentylene Glycol, Strelitzia Nicolai Seed Aril Extract, Sodium Dehydroacetate, Acrylates Copolymer, Polysorbate 60, Isopropyl Titanium Triisostearate, Citric Acid, Fructose, Sodium Hydroxide, Urea, Ethylhexylglycerin, Tromethamine, Magnesium Stearate, Sorbitan Isostearate, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium Pca, Trehalose, Aluminum Hydroxide, Sodium Laureth-12 Sulfate, Caprylyl Glycol, Glucose, Sodium Hyaluronate, C11-15 Pareth-7, Potassium Sorbate. *Mica, *Iron oxides, *Yellow 5, * Blue 1, *Chromium Oxide Greens, Ultramarine.

*contains one or more of these ingredients.


Advanced Ingredient Data


Raw Label Data

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