gr

gr
SPL v2
SPL
SPL Set ID 96dae912-8fa5-4d0e-b873-e1dbb7398db0
Route
topical
Published
Effective Date 2022-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (0.25 g) octinoxate (2.5 g)
Inactive Ingredients
water diphenylsiloxy phenyl trimethicone caprylyl trisiloxane dimethicone, unspecified butylene glycol glycerin bellis perennis flower peg-9 polydimethylsiloxyethyl dimethicone phenoxyethanol 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) dimethicone/peg-10/15 crosspolymer magnesium sulfate, unspecified form .alpha.-tocopherol acetate linoleic acid titanium dioxide polyethylene glycol 400 sodium chloride pentylene glycol dimethicone/vinyl dimethicone crosspolymer (soft particle) triethoxysilylethyl polydimethylsiloxyethyl hexyl dimethicone aluminum hydroxide tocopherol lactic acid, unspecified form serine sodium lactate sorbitol urea ethylhexylglycerin edetate disodium anhydrous hyaluronate sodium aluminum oxide stearic acid ascorbyl palmitate dipropylene glycol potassium sorbate sodium citrate, unspecified form ascorbic acid citric acid monohydrate linolenic acid allantoin sodium phosphate, dibasic, anhydrous ferric oxide red ferric oxide yellow ferrosoferric oxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-07-22 Until 2027-07-31

Purpose

Sunscreen

Description

Avobenzone 0.25% w/v Octinoxate 2.5% 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), Diphenylsiloxy Phenyl Trimethicone, Caprylyl Methicone, Dimethicone, Butylene Glycol, Glycerin, Bellis Perennis (Daisy) Flower Extract, Peg-9 Polydimethylsiloxyethyl Dimethicone, Phenoxyethanol, Acrylates/Dimethicone Copolymer, Dimethicone/Peg-10/15 Crosspolymer, Magnesium Sulfate, Tocopheryl Acetate, Linoleic Acid, Titanium Dioxide, Peg-8, Sodium Chloride, Pentylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Aluminum Hydroxide, Tocopherol, Lactic acid, Fragrance, Serine, Sodium Lactate, Sorbitol, Urea, Ethylhexylglycerin, Disodium Edta, Sodium Hyaluronate, Alumina, Stearic Acid, Ascorbyl Palmitate, Dipropylene Glycol, Potassium Sorbate, Sodium Citrate, Ascorbic Acid, Citric Acid, Linolenic Acid, Allantoin, Disodium Phosphate. *Iron Oxides.

*contains one or more of these ingredients.

Description

Avobenzone 0.25% w/v Octinoxate 2.5% w/v

Section 42229-5

GOLDEN ROSE

RADIANT TINTED MOISTURISER

HYDRATING SKIN TINT

Broad Spectrum SPF 25

01 FAIR TINT

02 MEDIUM TINT

03 DEEP TINT

• Radiant tinted moisturiser gives a healthy and fresh looking for the "no make-up look".

• The advanced non oily formula infused with hydrating complex and vitamins.

• SPF 25 sun protection shields your skin from the sun's harmful rays.

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 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 0.25% w/v

Octinoxate 2.5% 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), Diphenylsiloxy Phenyl Trimethicone, Caprylyl Methicone, Dimethicone, Butylene Glycol, Glycerin, Bellis Perennis (Daisy) Flower Extract, Peg-9 Polydimethylsiloxyethyl Dimethicone, Phenoxyethanol, Acrylates/Dimethicone Copolymer, Dimethicone/Peg-10/15 Crosspolymer, Magnesium Sulfate, Tocopheryl Acetate, Linoleic Acid, Titanium Dioxide, Peg-8, Sodium Chloride, Pentylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Aluminum Hydroxide, Tocopherol, Lactic acid, Fragrance, Serine, Sodium Lactate, Sorbitol, Urea, Ethylhexylglycerin, Disodium Edta, Sodium Hyaluronate, Alumina, Stearic Acid, Ascorbyl Palmitate, Dipropylene Glycol, Potassium Sorbate, Sodium Citrate, Ascorbic Acid, Citric Acid, Linolenic Acid, Allantoin, Disodium Phosphate. *Iron Oxides.

*contains one or more of these ingredients.

Section 42229-5 (42229-5)

GOLDEN ROSE

RADIANT TINTED MOISTURISER

HYDRATING SKIN TINT

Broad Spectrum SPF 25

01 FAIR TINT

02 MEDIUM TINT

03 DEEP TINT

• Radiant tinted moisturiser gives a healthy and fresh looking for the "no make-up look".

• The advanced non oily formula infused with hydrating complex and vitamins.

• SPF 25 sun protection shields your skin from the sun's harmful rays.

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 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 0.25% w/v

Octinoxate 2.5% w/v


Advanced Ingredient Data


Raw Label Data

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