FDA.reportPublic FDA data

Even Up Sunscreen SPF 50

Manufacturer
Colorescience
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:44:23

Label at a glance#

ProductEven Up Sunscreen SPF 50
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. Reapply: After 40 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: ask a doctor. 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 1...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 11.6%Sunscreen
Zinc Oxide 8.6%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
  • Reapply:
    • After 40 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours.
  • Children under 6 months: ask a doctor.
  • 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.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Isocetyl Stearoyl Stearate, Dimethicone Crosspolymer, Thermus Thermophillus Ferment, Water/Aqua/Eau, Hydrated Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium Lauriminodipropionate Tocopheryl Phosphates, Panthenyl Triacetate, Acetyl Rheum Rhaponticum Root Extract, Bidens Pilosa Extract, Elaeis Guineensis (Palm) Oil, Gossypium Herbaceum (Cotton) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Dimethiconol, Citrus Paradisi (Grapefruit) Seed Extract, Glycerin, Dimethicone, Fusanus Spicatus Wood Oil, Vanilla Planifolia Fruit Extract, Ascorbic Acid, Caprylic/Capric Triglyceride, Pentylene Glycol, Triethoxycaprylylsilane, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Potassium Sorbate, Farnesol, Iron Oxides (CI 77491, CI 77492, CI 77499).

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 866.426.5673

SPL UNCLASSIFIED SECTION

Dist. in USA by
colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

EVEN UP®

CLINICAL PIGMENT
PERFECTOR®

Brightens with Lumira®
ingredient complex

Improves look of discoloration

50
Broad Spectrum
SPF 50
Sunscreen

CHEMICAL-FREE ACTIVES | 100% MINERAL
WATER AND SWEAT RESISTANT, 40 MIN

1 fl. oz. / 30 mL

Principal Display Panel - 30 mL Bottle Carton
Principal Display Panel - 30 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68078-003-022021-10-06C16284748780-1ba0f9c33-53e4-a910-e053-dadaa90a0b85Even Up ® Sunscreen SPF 50
68078-003-042021-10-06C16284748780-1ba0f9c33-53e4-a910-e053-dadaa90a0b85Even Up ® Sunscreen SPF 50
68078-003-022021-01-29C16284748780-1ba0f9c33-53e4-a910-e053-dadaa90a0b85Even Up ® Sunscreen SPF 50
68078-003-042021-01-29C16284748780-1ba0f9c33-53e4-a910-e053-dadaa90a0b85Even Up ® Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-003-02Even Up Sunscreen SPF 501 mL in 1 PACKETLIQUID15
68078-003-04Even Up Sunscreen SPF 5030 mL in 1 TUBELIQUID305
68078-003-04Even Up Sunscreen SPF 501 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-003EVEN UP SUNSCREEN SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]5Current NDC, Legacy NDC, 3 package rows20241219_f9d375af-3c8b-4462-b729-fdd4be929284.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-00368078-003-04, 68078-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Cyclomethicone 50THT5PCI0RIACT
Isocetyl Stearoyl StearateIJV4LS383RIACT
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)9E4CO0W6C5IACT
Thermus Thermophilus Lysate775R692494IACT
Water059QF0KO0RIACT
Panthenol Triacetate, (+)-1206E8961BIACT
Disodium Lauriminodipropionate Tocopheryl Phosphates0K5Y9U1P6MIACT
GlycerinPDC6A3C0OXIACT
Dimethicone92RU3N3Y1OIACT
Palm Oil5QUO05548ZIACT
Cottonseed OilH3E878020NIACT
Citrus Paradisi Seed12F08874Y7IACT
TriethoxycaprylylsilaneLDC331P08EIACT
Linseed Oil84XB4DV00WIACT
Santalum Spicatum OilH9LVS6REV4IACT
Ascorbic AcidPQ6CK8PD0RIACT
Pentylene Glycol50C1307PZGIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
PhenoxyethanolHIE492ZZ3TIACT
VANILLA BEANQ74T35078HIACT
Potassium Sorbate1VPU26JZZ4IACT
Benzoic Acid8SKN0B0MIMIACT
Dehydroacetic Acid2KAG279R6RIACT
TocopherolR0ZB2556P8IACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
Hydrated SilicaY6O7T4G8P9IACT

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
Even Up Sunscreen SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef9d375af-3c8b-4462-b729-fdd4be9292842024-12-17WarningsExact identifier
ndc (package): 68078-003-02
ndc (package): 68078-003-04
ndc (product): 68078-003
ndc11 (package): 68078000304
ndc11 (package): 68078000302
spl id: d64579af-9050-4cd6-93d5-2003d4173096
spl set id: f9d375af-3c8b-4462-b729-fdd4be929284

Reported adverse events (FAERS/openFDA)#

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