FDA.reportPublic FDA data

Impact Fix Essence Make Up Base

Manufacturer
DongSung Pharm Co., Ltd. | Dong Sung World Wide USA, Inc. | Omar Sharif Cosmetic Co., Ltd.
Effective date
2020-12-09
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 23:02:58

Label at a glance#

ProductImpact Fix Essence Make Up Base SPF 10 / UVB Protection
Active ingredientTITANIUM DIOXIDE, OCTINOXATE
Label structure8 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

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.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2%

Titanium Dioxide 3%

Drug Facts

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPACT

FIX ESSENCE

MAKE UP BASE

SPF 10 / UVB Protection

moisturizing makeup base

Color 01 Light Green

carton imagecarton image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42361-10142361-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
MINERAL OILT5L8T28FGPIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
PROPYLPARABENZ8IX2SC1OHIACT
XANTHAN GUMTTV12P4NEEIACT
MACADAMIA OIL515610SU8CIACT
MORINDA CITRIFOLIA LEAF7UOL7P5FF5IACT
EDETATE DISODIUM7FLD91C86KIACT
TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATEN1TRQ06KVJIACT
BETAINE3SCV180C9WIACT
PETROLATUM4T6H12BN9UIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
TROLAMINE9O3K93S3TKIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYSORBATE 60CAL22UVI4MIACT
METHYLPARABENA2I8C7HI9TIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
LANOLIN OILOVV5IIJ58FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHROMIC OXIDEX5Z09SU859IACT
PURSLANEM6S840WXG5IACT
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c5dd83a9-26d6-d144-e053-2a95a90a62fbb7ba4cff-4336-40bb-98bb-410dde40ce472021-06-28WarningsExact identifier
spl set id: b7ba4cff-4336-40bb-98bb-410dde40ce47

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.