IMPACT FIX PRISM TWO WAY CAKE BROAD SPECTRUM SPF 24- octinoxate, titanium dioxide, zinc oxide powder

Impact Fix Prism Two Way Cake by

Drug Labeling and Warnings

Impact Fix Prism Two Way Cake 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

Octinoxate 1.4%

Titanium Dioxide 6.8%

Zinc Oxide 3.9%

Drug Facts

Purpose

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. If 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 shirt, pants, hats and sunglasses. For use on skin only.

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

At the end 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 after 40 minutes of swimming or sweating, immediately after towel drying and/or at least every 2 hours.

Children under 6 months: Ask a doctor.

Inactive Ingredients

Talc, Mica, Silica, Hexyl Laurate, Dimethicone, Iron Oxide (CI 77492), Diisostearyl Malate, Mineral Oil, Phenyl Trimethicone, Squalane, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxide (CI 77491), Dimethiconol Stearate, Fragrance, Iron Oxides (CI 77499), Methylparaben, Propylparaben, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Silk, Tocopheryl Acetate, Macadamia Integrifolia Seed Oil

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

IMPACT

FIX PRISM TWO WAY CAKE

Broad Spectrum SPF 24

moisturizing two way cake

Color No. Oak Beige

INGREDIENTS AND APPEARANCE

IMPACT FIX PRISM TWO WAY CAKE  BROAD SPECTRUM SPF 24
octinoxate, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42361-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	14 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	68 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	39 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHICONE (20 CST) (UNII: 6777U11MKT)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SQUALANE (UNII: GW89575KF9)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHYLPARABEN (UNII: A2I8C7HI9T)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MACADAMIA OIL (UNII: 515610SU8C)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42361-133-01	1 in 1 CARTON	12/21/2017
1		14 g in 1 CASE; Type 0: Not a Combination Product
2	NDC: 42361-133-02	14 g in 1 TRAY; Type 0: Not a Combination Product	12/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/21/2017

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(42361-133)

Establishment
Name	Address	ID/FEI	Business Operations
Omar Sharif Cosmetic Co., Ltd.		689316318	manufacture(42361-133) , pack(42361-133)