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

----------

42361-133 Drug Facts

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.

IMPACT

FIX PRISM TWO WAY CAKE

Broad Spectrum SPF 24

moisturizing two way cake

Color No. Oak Beige

carton top imagecarton bottom image

IMPACT FIX PRISM TWO WAY CAKE  BROAD SPECTRUM SPF 24
octinoxate, titanium dioxide, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42361-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE14 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE68 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION39 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42361-133-011 in 1 CARTON12/21/201706/28/2021
114 g in 1 CASE; Type 0: Not a Combination Product
2NDC:42361-133-0214 g in 1 TRAY; Type 0: Not a Combination Product12/21/201706/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/21/201706/28/2021
Labeler - DongSung Pharm Co., Ltd. (687856557)
Registrant - Dong Sung World Wide USA, Inc. (784969219)
Establishment
NameAddressID/FEIBusiness Operations
DongSung Pharm Co., Ltd.687856557label(42361-133)
Establishment
NameAddressID/FEIBusiness Operations
Omar Sharif Cosmetic Co., Ltd.689316318manufacture(42361-133) , pack(42361-133)

Revised: 6/2021
 
DongSung Pharm Co., Ltd.