Impact Fix Prism Two Way Cake

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 23:03:02

Label at a glance#

ProductImpact Fix Prism Two Way Cake Broad Spectrum SPF 24
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
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 skincare 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 1.4%

Titanium Dioxide 6.8%

Zinc Oxide 3.9%

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 of contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

At the end of basic skincare 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

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), Ultramarines (CI 77007), Methylparaben, Propylparaben, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Silk, Tocopheryl Acetate, Macadamia Integrifolia Seed Oil

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPACT

FIX PRISM TWO WAY CAKE

Broad Spectrum SPF 24

moisturizing two way cake

No. 23 True Beige

carton top imagecarton top imagecarton bottom imagecarton bottom image

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42361-12342361-123-01, 42361-123-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML · Source PDF

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-be33-614e-e053-2a95a90ab7c9f4d9b617-09aa-4b05-a79c-30abc17423d82021-06-28WarningsExact identifier
spl set id: f4d9b617-09aa-4b05-a79c-30abc17423d8

Reported adverse events (FAERS/openFDA)#

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