71261-030_jungsaemmool Essential Skin Nuder Cushion Light

71261-030_jungsaemmool Essential Skin Nuder Cushion Light
SPL v1
SPL
SPL Set ID bf24d081-85f7-4a26-9416-ecff1fe59dec
Route
TOPICAL
Published
Effective Date 2024-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (65.1 mg) Octinoxate (67 mg) Octisalate (40 mg)
Inactive Ingredients
Water Cyclomethicone 5 Glycerin Propanediol Trimethylsiloxysilicate (m/q 0.6-0.8) Peg-10 Dimethicone (200 Cst) Cetyl Ethylhexanoate Trisiloxane 1,2-hexanediol Caprylyl Trisiloxane Ferric Oxide Yellow Dimethicone Hydrogenated Coconut Oil Vinylpyrrolidone/hexadecene Copolymer Disteardimonium Hectorite Magnesium Sulfate, Unspecified Form 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Stearic Acid Ferric Oxide Red Aluminum Oxide Aluminum Hydroxide Glyceryl Monocaprylate Triethoxycaprylylsilane Ferrosoferric Oxide Dimethicone Crosspolymer Trisodium Ethylenediamine Disuccinate Butylated Hydroxytoluene Mica Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Stannic Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-29

Description

Titanium Dioxide 6.51% Octinoxate 6.70% Octisalate 4.00%


Medication Information

Warnings and Precautions

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 using and ask a doctor if rash occurs.

Indications and Usage

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration

For sunscreen use:

Apply liberally 15 minutes before sun exposure

Reapply at least every two 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 broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

Description

Titanium Dioxide 6.51% Octinoxate 6.70% Octisalate 4.00%

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, Cyclopentasiloxane, Titanium Dioxid (CI 77891), Glycerin, Propanediol, Trimethylsiloxysilicate, PEG-10 Dimethicone, Cetyl Ethylhexanoate, Trisiloxane, 1,2-Hexanediol, Caprylyl Methicone, Iron Oxides (CI 77492), Dimethicone, Hydrogenated Coconut Oil, Polypropylsilsesquioxane, VP/Hexadecene Copolymer, Synthetic Fluorphlogopite, Disteardimonium Hectorite, Magnesium Sulfate, Acrylates/Dimethicone Copolymer, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Iron Oxides (CI 77491), Alumina, Aluminum Hydroxide, Glyceryl Caprylate, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Fragrance(Parfum), Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, BHT, Mica (CI 77019), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tin Oxide (CI 77861)

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 6.51%

Octinoxate 6.70%

Octisalate 4.00%

Section 60561-8

Protect the product in the container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration (34068-7)

For sunscreen use:

Apply liberally 15 minutes before sun exposure

Reapply at least every two 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 broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

Warnings and Precautions (34071-1)

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 using and ask a doctor if rash occurs.

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Cyclopentasiloxane, Titanium Dioxid (CI 77891), Glycerin, Propanediol, Trimethylsiloxysilicate, PEG-10 Dimethicone, Cetyl Ethylhexanoate, Trisiloxane, 1,2-Hexanediol, Caprylyl Methicone, Iron Oxides (CI 77492), Dimethicone, Hydrogenated Coconut Oil, Polypropylsilsesquioxane, VP/Hexadecene Copolymer, Synthetic Fluorphlogopite, Disteardimonium Hectorite, Magnesium Sulfate, Acrylates/Dimethicone Copolymer, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Iron Oxides (CI 77491), Alumina, Aluminum Hydroxide, Glyceryl Caprylate, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Fragrance(Parfum), Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, BHT, Mica (CI 77019), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tin Oxide (CI 77861)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 6.51%

Octinoxate 6.70%

Octisalate 4.00%

Section 60561-8 (60561-8)

Protect the product in the container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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