Gr

Gr
SPL v2
SPL
SPL Set ID 1eba51f2-782e-480e-8555-f5ad8883fa0d
Route
TOPICAL
Published
Effective Date 2022-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1 g) Oxybenzone (0.1 g)
Inactive Ingredients
Water Cyclomethicone 5 Hydrogenated Polydecene (3100 Cst) Glycerin Propylene Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Talc Polyglyceryl-3 Diisostearate Disteardimonium Hectorite Phenoxyethanol Peg/ppg-18/18 Dimethicone Sodium Chloride Dimethicone, Unspecified Silica Dimethyl Silylate Propylene Carbonate Aluminum Hydroxide Hydrogen Dimethicone (13 Cst) Trimethylsiloxysilicate (m/q 0.6-0.8) Allantoin Sodium Benzoate Xanthan Gum Titanium Dioxide .alpha.-tocopherol Acetate Edetate Disodium Anhydrous Levomenol Magnesium Stearate Ethylhexylglycerin Triethoxycaprylylsilane Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-07-22 Until 2029-07-31

Description

Octinoxate 1% w/v Oxybenzone 0.1% w/v

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 1% w/v Oxybenzone 0.1% 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

SPF 15

VITAMIN E

DERMATOLOGICALLY TESTED

Manufactured By:

ERKUL COSMETICS San. Tic. A.Ş.,

Petrol Ofisi Cad. No:1

Avcılar, ISTANBUL, TURKIYE,

34310

Phone: +90 212 456 53 00

www.goldenrose.com.tr

[email protected]

MADE IN TURKIYE

Distributed By:

CELESTY LLC

3970 NW 167TH ST.

MIAMI GARDENS,

FL 33054 – USA

[email protected]

EU R.P.: REACH Global Services SA, 

6 Rond point Schuman Brussels

1040 BELGIUM

NO:21

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 1% w/v

Oxybenzone 0.1% w/v

Inactive Ingredients

Water(Aqua), Cyclopentasiloxane, Hydrogenated Polydecene, Glycerin, Propylene Gylcol, Cetyl Peg/Ppg-10/1 Dimethicone, Talc, Polyglyceryl-3 Diisostearate, Disteardimonium Hectorite, Phenoxyethanol, Peg/Ppg-18/18 Dimethicone, Sodium Chloride, Dimethicone, Silica Dimethyl Silylate, Propylene Carbonate, Aluminum Hydroxide, Hydrogen Dimethicone, Trimethylsiloxysilicate, Allantoin, Sodium Benzoate, Xanthan gum, Titanium Dioxide, Tocopheryl Acetate, Fragrance, Disodium Edta, Bisabolol, Magnesium Stearate, Ethylhexylglycerin, Triethoxycaprylylsilane *Iron Oxides. *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

SPF 15

VITAMIN E

DERMATOLOGICALLY TESTED

Manufactured By:

ERKUL COSMETICS San. Tic. A.Ş.,

Petrol Ofisi Cad. No:1

Avcılar, ISTANBUL, TURKIYE,

34310

Phone: +90 212 456 53 00

www.goldenrose.com.tr

[email protected]

MADE IN TURKIYE

Distributed By:

CELESTY LLC

3970 NW 167TH ST.

MIAMI GARDENS,

FL 33054 – USA

[email protected]

EU R.P.: REACH Global Services SA, 

6 Rond point Schuman Brussels

1040 BELGIUM

NO:21

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 1% w/v

Oxybenzone 0.1% w/v

Inactive Ingredients (Inactive ingredients)

Water(Aqua), Cyclopentasiloxane, Hydrogenated Polydecene, Glycerin, Propylene Gylcol, Cetyl Peg/Ppg-10/1 Dimethicone, Talc, Polyglyceryl-3 Diisostearate, Disteardimonium Hectorite, Phenoxyethanol, Peg/Ppg-18/18 Dimethicone, Sodium Chloride, Dimethicone, Silica Dimethyl Silylate, Propylene Carbonate, Aluminum Hydroxide, Hydrogen Dimethicone, Trimethylsiloxysilicate, Allantoin, Sodium Benzoate, Xanthan gum, Titanium Dioxide, Tocopheryl Acetate, Fragrance, Disodium Edta, Bisabolol, Magnesium Stearate, Ethylhexylglycerin, Triethoxycaprylylsilane *Iron Oxides. *contains one or more of these ingredients.


Advanced Ingredient Data


Raw Label Data

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