Gr

Gr
SPL v2
SPL
SPL Set ID 3b22579b-21ce-4b96-bd24-774ce35bf6f7
Route
TOPICAL
Published
Effective Date 2022-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.5 g) Oxybenzone (0.25 g) Titanium Dioxide (4.95 g)
Inactive Ingredients
Water Cyclomethicone 5 Isododecane Glycerin Peg-9 Polydimethylsiloxyethyl Dimethicone Butylene Glycol Phenyl Trimethicone Talc 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Silica Dimethyl Silylate Sodium Chloride Phenoxyethanol Disteardimonium Hectorite Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethicone, Unspecified .alpha.-tocopherol Acetate Peg/ppg-18/18 Dimethicone Strelitzia Nicolai Whole Propylene Carbonate Pentylene Glycol Potassium Sorbate Edetate Disodium Anhydrous Sorbic Acid Triethoxycaprylylsilane Lactic Acid, Unspecified Form Serine Sodium Lactate Sorbitol Urea Magnesium Stearate Silicon Dioxide Isoceteth-10 Aluminum Hydroxide Allantoin Linalool, (+/-)- Mica Ferric Oxide Red Bismuth Oxychloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-06-06 Until 2029-06-30

Description

Octinoxate 2.5% w/v Oxybenzone 0.25% w/v Titanium Dioxide 4.95% w/v

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 2.5% w/v Oxybenzone 0.25% w/v Titanium Dioxide 4.95% 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

BB CREAM

BEAUTY BALM

Broad Spectrum SPF 25

All in One, Instantly Perfect Looking Skin!

• Gives a smooth finish look with its light and easy to apply texture.

• Provides hydration to the skin during the day.

• SPF 25 (UVA/UVB) protects your skin against the harmful sunrays.

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 167 TH 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 2.5% w/v

Oxybenzone 0.25% w/v

Titanium Dioxide 4.95% w/v

Inactive Ingredients

Water (Aqua), Cyclopentasiloxane, Isododecane, Glycerin, PEG-9 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Phenyl Trimethicone, Talc, Acrylates/Dimethicone Copolymer, Silica Dimethyl Silylate, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Tocopheryl Acetate, PEG/PPG-18 /18 Dimethicone, White Bird of Paradise (Strelitzia nicolai) Seed Aril Extract, Propylene Carbonate, Pentylene Glycol, Potassium Sorbate, Disodium EDTA, Sorbic Acid, Triethoxycaprylylsilane, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Magnesium Stearate, Fragrance, Silica, Isoceteth-10, Aluminum Hydroxide, Allantoin, Linalool, Mica*, Iron Oxides*, Bismuth Oxychloride*.

* 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)

BB CREAM

BEAUTY BALM

Broad Spectrum SPF 25

All in One, Instantly Perfect Looking Skin!

• Gives a smooth finish look with its light and easy to apply texture.

• Provides hydration to the skin during the day.

• SPF 25 (UVA/UVB) protects your skin against the harmful sunrays.

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 167 TH 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 2.5% w/v

Oxybenzone 0.25% w/v

Titanium Dioxide 4.95% w/v

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cyclopentasiloxane, Isododecane, Glycerin, PEG-9 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Phenyl Trimethicone, Talc, Acrylates/Dimethicone Copolymer, Silica Dimethyl Silylate, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Tocopheryl Acetate, PEG/PPG-18 /18 Dimethicone, White Bird of Paradise (Strelitzia nicolai) Seed Aril Extract, Propylene Carbonate, Pentylene Glycol, Potassium Sorbate, Disodium EDTA, Sorbic Acid, Triethoxycaprylylsilane, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Magnesium Stearate, Fragrance, Silica, Isoceteth-10, Aluminum Hydroxide, Allantoin, Linalool, Mica*, Iron Oxides*, Bismuth Oxychloride*.

* contains one or more of these ingredients


Advanced Ingredient Data


Raw Label Data

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