OS SILKY SUN CUSHION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide lotion

OS SILKY SUN CUSHION by

Drug Labeling and Warnings

OS SILKY SUN CUSHION by is a Otc medication manufactured, distributed, or labeled by DongSung Pharm Co., Ltd., Dong Sung World Wide USA, Inc., Omar Sharif Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Ethylhexyl Methoxycinnamate 7.4%

Octocrylene 3.0%

Phenylbenzimidazole Sulfonic Acid 3.9%

Titanium Dioxide 4.9%

Zinc Oxide 4.9%

Drug Facts

Sunscreen

Uses

Helps to 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.

Warnings

For external use only. Do not use on damaged or broken skin. Discontinue use if signs of irritation or rash appear. Avoid contact with eyes. Wash off immediately with cold water if product comes in contact with eyes. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Warnings

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

Apply liberally on face 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. and wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Methyl Methacrylate Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Quaternium-18 Bentonite, Sodium Hydroxide, Aluminum Hydroxide, Stearic Acid, Fragrance, Chlorphenesin, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxide (CI 77491, CI 77492), Tocopheryl Acetate, Hydrolyzed Silk, Royal Jelly Extract, Dimethicone, 1,2-Hexanediol, Sodium Hyaluronate, Phenoxyethanol, Ethylhexylglycerin

PRINCIPAL DISPLAY PANEL

OS Silky Sun Cushion

Broad Spectrum SPF 50+

INGREDIENTS AND APPEARANCE

OS SILKY SUN CUSHION  BROAD SPECTRUM SPF 50
ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42361-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.036 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.697 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.686 g  in 14 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.42 g  in 14 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.546 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BENTOQUATAM (UNII: 7F465U79Q1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ROYAL JELLY (UNII: L497I37F0C)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42361-158-01	1 in 1 CARTON	05/25/2019
1		14 g in 1 CASE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/25/2019

Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661)

Registrant - Dong Sung World Wide USA, Inc. (784969219)

Establishment
Name	Address	ID/FEI	Business Operations
Dong Sung Bio Pharm. Co., Ltd.		687811661	label(42361-158)

Establishment
Name	Address	ID/FEI	Business Operations
Omar Sharif Cosmetic Co., Ltd.		689316318	manufacture(42361-158)