OS SILKY SUN CUSHION by Omar Sharif Cosmetic Co., Ltd. / Dong Sung World Wide USA, Inc. 82070-030 Drug Facts

OS SILKY SUN CUSHION by

Drug Labeling and Warnings

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

Drug Details [pdf]

OS SILKY SUN CUSHION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide lotion 
Omar Sharif Cosmetic Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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82070-030 Drug Facts

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

OS Silky Sun Cushion

Broad Spectrum SPF 50+

Product carton image

OS SILKY SUN CUSHION  BROAD SPECTRUM SPF 50
ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82070-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.036 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.697 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.686 g  in 14 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.42 g  in 14 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.546 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82070-030-011 in 1 CARTON05/25/201909/17/2021
114 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/25/201909/17/2021
Labeler - Omar Sharif Cosmetic Co., Ltd. (689316318)
Registrant - Dong Sung World Wide USA, Inc. (784969219)
Establishment
NameAddressID/FEIBusiness Operations
Omar Sharif Cosmetic Co., Ltd.689316318pack(82070-030) , manufacture(82070-030) , label(82070-030)

Revised: 7/2022