Gr

Gr
SPL v2
SPL
SPL Set ID 62759398-4935-4732-b950-cfbeab82bc5a
Route
TOPICAL
Published
Effective Date 2022-08-01
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 Allantoin Dichlorobenzyl Alcohol Magnesium Stearate Mica Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-07-22 Until 2029-04-30

Description

Octinoxate 1.995% w/v

Purpose

Sun Screen


Medication Information

Purpose

Sun Screen

Description

Octinoxate 1.995% 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

SPF 15

LONG LASTING UP TO 16HR

• Good Coverage

• Silky, Smooth and Soft Finish

• Shine Control

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: 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 1.995% w/v

Inactive Ingredients

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

SPF 15

LONG LASTING UP TO 16HR

• Good Coverage

• Silky, Smooth and Soft Finish

• Shine Control

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: 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

Sun Screen

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 1.995% w/v

Inactive Ingredients (Inactive ingredients)

Talc, Dimethicone, Silica, Polymethyl Methacrylate, Zinc Stearate, Diisostearyl Malate, Hexyl Laurate, Triethoxycaprylylsilane, Aluminum Hydroxide, Titanium Dioxide, Phenoxyethanol, Allantoin, Dichlorobenzyl Alcohol, Magnesium Stearate, *Mica, *Iron Oxodes. *contains one or more of these ingredients.


Advanced Ingredient Data


Raw Label Data

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