IMPACT FIX ESSENCE MAKE UP BASE SPF 10 / UVB PROTECTION- octinoxate, titanium dioxide cream

Impact Fix Essence Make Up Base by

Drug Labeling and Warnings

Impact Fix Essence Make Up Base 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 2%

Titanium Dioxide 3%

Drug Facts

Sunscreen

Uses

Helps prevent sunburn.

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 ingesting, seek professional assistance or contact a Poison Control Center right away.

Skin Cancer/Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Skin protection measures : 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. 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

Water, Butylene Glycol, Glycerin, Triethylhexanoin, Trimethylolpropane Tricaprylate/Tricaprate, Betaine, Stearic Acid, Mineral Oil, Dimethicone, Cetearyl Alcohol, Petrolatum, Sorbitan Sesquioleat, Lanolin Oil, Triethanolamine, Magnesium Aluminum Silicate, Glyceryl Stearate, Polysorbate 60, Tocopheryl Acetate, Fragrance, Chromium Oxide Greens, Methylparaben, Propylparaben, Xanthan Gum, Macadamia Integrifolia Seed Oil, Morinda Citrifolia Extract, Disodium EDTA, Hydrolyzed Silk, Portulaca Olearacea Extract

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

IMPACT

FIX ESSENCE

MAKE UP BASE

SPF 10 / UVB Protection

moisturizing makeup base

Color 01 Light Green

INGREDIENTS AND APPEARANCE

IMPACT FIX ESSENCE MAKE UP BASE  SPF 10 / UVB PROTECTION
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42361-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
MACADAMIA OIL (UNII: 515610SU8C)
MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)
BETAINE (UNII: 3SCV180C9W)
PETROLATUM (UNII: 4T6H12BN9U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TROLAMINE (UNII: 9O3K93S3TK)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LANOLIN OIL (UNII: OVV5IIJ58F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHROMIC OXIDE (UNII: X5Z09SU859)
PURSLANE (UNII: M6S840WXG5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42361-101-01	1 in 1 CARTON	12/21/2017
1		40 g in 1 BOTTLE; 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	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(42361-101)

Establishment
Name	Address	ID/FEI	Business Operations
Omar Sharif Cosmetic Co., Ltd.		689316318	manufacture(42361-101) , pack(42361-101)