71261-034_jungsaemmool Essential Skin Nuder Cushion Medium Deep

71261-034_jungsaemmool Essential Skin Nuder Cushion Medium Deep
SPL v1
SPL
SPL Set ID 0e18d601-700a-4c1c-a434-22582253bd95
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) Ferric Oxide Yellow Peg-10 Dimethicone (200 Cst) Cetyl Ethylhexanoate Trisiloxane 1,2-hexanediol Caprylyl Trisiloxane 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) Ferric Oxide Red Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Ferrosoferric Oxide Triethoxycaprylylsilane Stearic Acid Aluminum Oxide Aluminum Hydroxide Glyceryl Monocaprylate 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 Dioxide (CI 77891), Glycerin, Propanediol, Trimethylsiloxysilicate, Iron Oxides (CI 77492), PEG-10 Dimethicone, Cetyl Ethylhexanoate, Trisiloxane, 1,2-Hexanediol, Caprylyl Methicone, Dimethicone, Hydrogenated Coconut Oil, Polypropylsilsesquioxane, VP/Hexadecene Copolymer, Disteardimonium Hectorite, Magnesium Sulfate, Acrylates/Dimethicone Copolymer, Iron Oxides (CI 77491), Cetyl PEG/PPG-10/1 Dimethicone, Synthetic Fluorphlogopite, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Stearic Acid, Alumina, Aluminum Hydroxide, Glyceryl Caprylate, 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 Dioxide (CI 77891), Glycerin, Propanediol, Trimethylsiloxysilicate, Iron Oxides (CI 77492), PEG-10 Dimethicone, Cetyl Ethylhexanoate, Trisiloxane, 1,2-Hexanediol, Caprylyl Methicone, Dimethicone, Hydrogenated Coconut Oil, Polypropylsilsesquioxane, VP/Hexadecene Copolymer, Disteardimonium Hectorite, Magnesium Sulfate, Acrylates/Dimethicone Copolymer, Iron Oxides (CI 77491), Cetyl PEG/PPG-10/1 Dimethicone, Synthetic Fluorphlogopite, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Stearic Acid, Alumina, Aluminum Hydroxide, Glyceryl Caprylate, 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:22.208235 · Updated: 2026-03-14T23:03:24.276357