gr 

gr 
SPL v2
SPL
SPL Set ID e36550a6-a231-41a8-abda-afdbb2449eaa
Route
topical
Published
Effective Date 2022-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (0.1 g) octinoxate (1 g)
Inactive Ingredients
water cyclomethicone 5 peg-10 dimethicone (600 cst) isononyl isononanoate talc dimethicone, unspecified cyclomethicone 6 methylpropanediol silicon dioxide sodium chloride phenoxyethanol dimethicone crosspolymer (450000 mpa.s) titanium dioxide .alpha.-tocopherol acetate triethoxycaprylylsilane glycerin pentylene glycol disodium stearoyl glutamate lactic acid, unspecified form serine sodium lactate sorbitol urea isostearyl sebacate aluminum hydroxide magnesium stearate allantoin linalool, (+/-)- ferric oxide red ferric oxide yellow ferrosoferric oxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-07-22 Until 2028-09-30

Purpose

Sunscreen

Description

Avobenzone 0.1% w/v 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, Peg-10 Dimethicone, Isononyl Isononanoate, Talc, Dimethicone, Cyclohexasiloxane, Methylpropanediol, Silica, Sodium Chloride, Phenoxyethanol, Dimethicone Crosspolymer, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Glycerin, Pentylene Glycol, Disodium Stearoyl Glutamate, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Isostearyl Sebacate, Aluminum Hydroxide, Fragrance, Magnesium Stearate, Allantoin, Linalool, *Iron Oxides. *contains one or more of these ingredients.

Description

Avobenzone 0.1% w/v Octinoxate 1% w/v

Section 42229-5

GOLDEN ROSE

SOFT FOCUS FLAWLESS FINISH

SPF 15

• Blurs imperfections' look

• Medium coverage

• Lightweight & Hydrating

DERMATOLOGICALLY TESTED

101 PORCELAIN

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: 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

Avobenzone 0.1% w/v

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, Peg-10 Dimethicone, Isononyl Isononanoate, Talc, Dimethicone, Cyclohexasiloxane, Methylpropanediol, Silica, Sodium Chloride, Phenoxyethanol, Dimethicone Crosspolymer, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Glycerin, Pentylene Glycol, Disodium Stearoyl Glutamate, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Isostearyl Sebacate, Aluminum Hydroxide, Fragrance, Magnesium Stearate, Allantoin, Linalool, *Iron Oxides. *contains one or more of these ingredients.

Section 42229-5 (42229-5)

GOLDEN ROSE

SOFT FOCUS FLAWLESS FINISH

SPF 15

• Blurs imperfections' look

• Medium coverage

• Lightweight & Hydrating

DERMATOLOGICALLY TESTED

101 PORCELAIN

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: 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)

Avobenzone 0.1% w/v

Octinoxate 1% w/v


Advanced Ingredient Data


Raw Label Data

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