RE20 ULTRA SUN DEFENSE SPECIAL SET BROAD SPECTRUM SPF 44- octinoxate, titanium dioxide, zinc oxide cream

Re20 Ultra Sun Defense Special Set by

Drug Labeling and Warnings

Re20 Ultra Sun Defense Special Set 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]

Uses

Not only will it help prevent sunburn, it also reduces the risk of skin cancer and early skin aging if used as directed with other sun protection measures. (SPF value of 15 or higher)

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. 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. This product contains iodopropynyl butylcarbamate (IPBC) and is not to be used for children under 3 years.

Allergy alert: Contains iodopropynyl butylcarbamate (IPBC).

Directions

At the last stage of basic skin care regimen, apply liberally on face to cover the entire facial area and lightly go over parts where extra cover-up is needed with detailed perfection. Apply 15 minutes before sun exposure. For added protection, reapply at least every 2 hours, after swimming, towel drying or extended sun exposure. Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor.

Inactive Ingredients

Water, Butylene Glycol, Cetyl Ethylhexanoate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Cyclomethicone, Isopropyl Myristate, Cyclohexasiloxane, Butyrospermum Parkii (Shea Butter), Fragrance, Hexyl Laurate, Quaternium-18 Bentonite, Magnesium Sulfate, Alumina, Dimethicone Copolyol, Scuttellaria Baicalensis Root Extract, Tocopheryl Acetate, DMDM Hydantoin, Dimethicone, Allantoin, Iodopropynyl Butylcarbamate, Sodium Hyaluronate

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

Re20

ULTRA SUN DEFENSE SPECIAL SET

ULTRA DEFENSE DU SOLEIL

BROAD SPECTRUM SPF 44

OMAR SHARIF PARIS

INGREDIENTS AND APPEARANCE

RE20 ULTRA SUN DEFENSE SPECIAL SET  BROAD SPECTRUM SPF 44
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42361-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	24 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	29 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SHEA BUTTER (UNII: K49155WL9Y)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENTOQUATAM (UNII: 7F465U79Q1)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42361-202-01	1 in 1 CARTON	06/06/2014
1		60 g in 1 TUBE; 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	06/06/2014

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(42361-202)

Establishment
Name	Address	ID/FEI	Business Operations
Omar Sharif Cosmetic Co., Ltd.		689316318	pack(42361-202) , manufacture(42361-202)