FDA.reportPublic FDA data

Impact Fix Pure Essence Foundation

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
10
Source
legacy-cache
Hydrated at
2026-08-01 23:02:54

Label at a glance#

ProductImpact Fix Pure Essence Foundation Broad Spectrum SPF 20
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Indications and 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)

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 9.9%

Drug Facts

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

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 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. 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, Cyclopentasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Nylon12, Cyclohexasiloxane, PEG-10 Dimethicone, Iron Oxide (CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Iron Oxides (CI 77491, CI 77499), Quaternium-18 Bentonite, Fragrance, Methylparaben, Disodium EDTA, Vitis Vinifera (Grape) Seed Oil, Macadamia Integrifolia Seed oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Silk, Tocopheryl Acetate, Ceramide 3

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPACT

FIX PURE ESSENCE FOUNDATION

Broad Spectrum SPF 20

moisturizing foundation

Color No. 35 Ocher Beige

carton imagecarton image

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42361-13542361-135-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE YELLOWEX438O2MRTIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
METHYLPARABENA2I8C7HI9TIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CERAMIDE 34370DF050BIACT
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
NYLON-12446U8J075BIACT
SODIUM CHLORIDE451W47IQ8XIACT
FERRIC OXIDE RED1K09F3G675IACT
BENTOQUATAM7F465U79Q1IACT
EDETATE DISODIUM7FLD91C86KIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
MACADAMIA OIL515610SU8CIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT

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
c5dd8898-be38-614e-e053-2a95a90ab7c9a2a00ef8-da75-4e77-b76d-db9f8fede2512021-06-28WarningsExact identifier
spl set id: a2a00ef8-da75-4e77-b76d-db9f8fede251

Reported adverse events (FAERS/openFDA)#

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