Golden Rose 

Golden Rose 
SPL v2
SPL
SPL Set ID cca417c8-b882-48a7-8bd8-ccc6f961a3d2
Route
TOPICAL
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.995 g)
Inactive Ingredients
Talc Dimethicone, Unspecified Silicon Dioxide Poly(methyl Methacrylate; 450000 Mw) Zinc Stearate Diisostearyl Malate Hexyl Laurate Triethoxycaprylylsilane Aluminum Hydroxide Titanium Dioxide Phenoxyethanol Hydrogen Dimethicone (13 Cst) Allantoin Dichlorobenzyl Alcohol Magnesium Stearate Mica Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-02-14 Until 2029-06-30

Description

Octinoxate 1.995% w/w

Purpose

SunScreen


Medication Information

Purpose

SunScreen

Description

Octinoxate 1.995% w/w

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

Multi-use cream palette is ideal for correcting discolorations; concealing dark under-eye circles and spot imperfections or light shades for highlighting and dark shades for contouring your face features. Setting Powder with SPF 20 sets concealer and corrector for longwear make up.

DERMATOLOGICALLY & OPHTHALMOLOGICALLY TESTED

Setting Powder SPF 20

IVORY Concealer

NEUTRAL Concealer

LIGHT BEIGE Corrector

LIGHT BISQUE Corrector

MEDIUM Corrector

Manufactured By: 

ERKUL COSMETICS San. Tic. A.S., 

Petrol Ofisi Cad. No:1 Avcılar, ÍSTANBUL, TÜRKÍYE, 34310

Phone: +90 212 456 53 00

www.goldenrose.com.tr    [email protected]

MADE IN TÜRKÍYE

Distributed By:

CELESTY LLC

3970 NW 167TH ST. MIAMI GARDENS, FL 33054-USA

[email protected]

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 20 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 1.995% w/w

Inactive Ingredients

Talc, Dimethicone, Silica, Polymethyl Methacrylate, Zinc Stearate, Diisostearyl Malate, Hexyl Laurate, Triethoxycaprylylsilane, Aluminum Hydroxide, Titanium Dioxide, Phenoxyethanol, Hydrogen Dimethicone, Allantoin, Dichlorobenzyl Alcohol, Magnesium Stearate, *Mica, *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)

Multi-use cream palette is ideal for correcting discolorations; concealing dark under-eye circles and spot imperfections or light shades for highlighting and dark shades for contouring your face features. Setting Powder with SPF 20 sets concealer and corrector for longwear make up.

DERMATOLOGICALLY & OPHTHALMOLOGICALLY TESTED

Setting Powder SPF 20

IVORY Concealer

NEUTRAL Concealer

LIGHT BEIGE Corrector

LIGHT BISQUE Corrector

MEDIUM Corrector

Manufactured By: 

ERKUL COSMETICS San. Tic. A.S., 

Petrol Ofisi Cad. No:1 Avcılar, ÍSTANBUL, TÜRKÍYE, 34310

Phone: +90 212 456 53 00

www.goldenrose.com.tr    [email protected]

MADE IN TÜRKÍYE

Distributed By:

CELESTY LLC

3970 NW 167TH ST. MIAMI GARDENS, FL 33054-USA

[email protected]

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 20 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 1.995% w/w

Inactive Ingredients (Inactive ingredients)

Talc, Dimethicone, Silica, Polymethyl Methacrylate, Zinc Stearate, Diisostearyl Malate, Hexyl Laurate, Triethoxycaprylylsilane, Aluminum Hydroxide, Titanium Dioxide, Phenoxyethanol, Hydrogen Dimethicone, Allantoin, Dichlorobenzyl Alcohol, Magnesium Stearate, *Mica, *Iron Oxides

*contains one or more of these ingredients.


Advanced Ingredient Data


Raw Label Data

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