OMAR SHARIF EVERYDAY SUN PROTECTION BROAD SPECTRUM SPF 50- amiloxate, bemotrizinol, octinoxate, titanium dioxide, zinc oxide lotion 
Dong Sung Bio Pharm. 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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Drug Facts 42361-250

Drug Facts

Amiloxate 2%

Benmotrizinol 3%

Octinoxate 7.5%

Titanium Dioxide 1.1%

Zinc Oxide 2.5%

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.

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.

Inactive Ingredients

Water, Dicaprylyl Carbonate, Glycerin, Cyclomethicone, Cyclopentasiloxane, Octyldodecanol, Cyclohexasiloxane, Behenyl Alcohol, Glyceryl Stearate, Cetearyl Alcohol, Cetyl Dimethicone, Diisostearyl Malate, Polyglyceryl-10 Pentastearate, PEG-40 Stearate, PEG-10 Dimethicone, VP/Eicosene Copolymer, Stearyl Dimethicone, Sorbitan Sesquioleate, PEG-100 Stearate, Fragrance, Sodium Stearoyl Lactylate, Polyacrylamide, Cetearyl Glucoside, Methylparaben, C13-14 Isoparaffin, Butylene Glycol, Laureth-7, Stearic Acid, Methicone, Aluminum Hydroxide, Propylparaben, Ammonium Acryloyldimethyltaurate/VP Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Camellia Japonica Flower Extract, Allantoin, Tocopheryl Acetate, Disodium EDTA, Simmondsia Chinensis (Jojoba) Seed Oil, Macadamia Integrifolia Seed Oil, Yeast Extract, Bacillus/Glutamic Acid Ferment Filtrate, Sodium Hyaluronate, Levan, Portulaca Oleracea Extract

Omar Sharif Everyday Sun Protection

Broad Spectrum SPF 50+

Illuminating Facial Sunscreen

Fast-absorbing, lightweight everyday sunscreen that provides protection against both UVA&UVB

carton image

OMAR SHARIF EVERYDAY SUN PROTECTION  BROAD SPECTRUM SPF 50
amiloxate, bemotrizinol, octinoxate, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42361-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL30 mg  in 1 g
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DOCOSANOL (UNII: 9G1OE216XY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MACADAMIA OIL (UNII: 515610SU8C)  
YEAST (UNII: 3NY3SM6B8U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LAURETH-7 (UNII: Z95S6G8201)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42361-250-011 in 1 CARTON09/19/2016
180 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/19/201606/21/2017
Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661)
Registrant - Dong Sung World Wide USA, Inc. (784969219)
Establishment
NameAddressID/FEIBusiness Operations
Dong Sung Bio Pharm. Co., Ltd.687811661label(42361-250)
Establishment
NameAddressID/FEIBusiness Operations
Omar Sharif Cosmetic Co., Ltd.689316318manufacture(42361-250)

Revised: 6/2017
 
Dong Sung Bio Pharm. Co., Ltd.