FDA.reportPublic FDA data

Sunforgettable Total Protection Brush-On Shield SPF 50

Manufacturer
Colorescience
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:02

Label at a glance#

ProductSunforgettable Total Protection Brush-On Shield 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 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months of age: 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 val...

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 22.5%Sunscreen
Zinc Oxide 22.5%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 80 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours.
  • Children under 6 months of age:
    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

Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol/Propylsilsequioxane/Silicate Crosspolymer, Lycopodium Clavatum Extract, Sodium Hyaluronate, Imperata Cyclindrica Root Extract, Glycerin, Water, Caesalpinia Spinosa Fruit Pod Extract, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis Leaf Extract, Quercus Robur (Oak) Wood Extract, Helianthus Annuus (Sunflower) Sprout Extract, Maltodextrin, Methicone, Triethoxycaprylylsilane, Laureth-4, Sodium Benzoate, Potassium Sorbate, Chromium Oxide Greens (CI 77288), Iron Oxides (CI77491, 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

Distributed in USA by
colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

SUNFORGETTABLE®
TOTAL PROTECTION®

BRUSH-ON SHIELD BRONZE

  • Protects from: UVA/UVB,
    pollution, blue light, IR
  • Natural-looking bronze tint
  • Hydrating, antioxidant-rich

50
Broad Spectrum
SPF 50 Sunscreen
PA++++

ALL-MINERAL ACTIVES
WATER/SWEAT RESISTANT (80 MINUTES)

Net Wt. 4.3 g / 0.15 oz.

Principal Display Panel - 4.3 g Tube Carton
Principal Display Panel - 4.3 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68078-027-012021-10-08C16284748780-1ba0f9c33-1967-a910-e053-dadaa90a0b85Sunforgettable ® Total Protection™ Brush-On Shield SPF 50
68078-027-022021-10-08C16284748780-1ba0f9c33-1967-a910-e053-dadaa90a0b85Sunforgettable ® Total Protection™ Brush-On Shield SPF 50
68078-027-012021-01-29C16284748780-1ba0f9c33-1967-a910-e053-dadaa90a0b85Sunforgettable ® Total Protection™ Brush-On Shield SPF 50
68078-027-022021-01-29C16284748780-1ba0f9c33-1967-a910-e053-dadaa90a0b85Sunforgettable ® Total Protection™ Brush-On Shield SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-027-01Sunforgettable Total Protection Brush-On Shield SPF 501 in 1 CARTONPOWDER14
68078-027-01Sunforgettable Total Protection Brush-On Shield SPF 506 g in 1 TUBE, WITH APPLICATORPOWDER64
68078-027-02Sunforgettable Total Protection Brush-On Shield SPF 502 g in 1 TUBE, WITH APPLICATORPOWDER24
68078-027-03Sunforgettable Total Protection Brush-On Shield SPF 504.3 g in 1 TUBE, WITH APPLICATORPOWDER4.34
68078-027-03Sunforgettable Total Protection Brush-On Shield SPF 501 in 1 CARTONPOWDER14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-027SUNFORGETTABLE TOTAL PROTECTION BRUSH-ON SHIELD SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [COLORESCIENCE]4Current NDC, Legacy NDC, 5 package rows20241218_c77357f1-7ada-4325-86f7-5ee801610f42.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-02768078-027-01, 68078-027-02, 68078-027-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
MicaV8A1AW0880IACT
Dimethicone/Vinyl Dimethicone Crosspolymer (Hard Particle)H895X08VNQIACT
Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer (450000000 MW)9KB5R958PBIACT
Maltodextrin7CVR7L4A2DIACT
Methicone (20 CST)6777U11MKTIACT
GlycerinPDC6A3C0OXIACT
Laureth-46HQ855798JIACT
Hyaluronate SodiumYSE9PPT4THIACT
Imperata Cylindrica RootVYT2JA85NHIACT
Water059QF0KO0RIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Vitis Vinifera SeedC34U15ICXAIACT
Green Tea LeafW2ZU1RY8B0IACT
Quercus Robur Twig Bark2JFK226947IACT
TARA SPINOSA RESINWL3883U2POIACT
Sunflower Oil3W1JG795YIIACT
Potassium Sorbate1VPU26JZZ4IACT
Sodium BenzoateOJ245FE5EUIACT
Ferric Oxide YellowEX438O2MRTIACT
Ferrosoferric OxideXM0M87F357IACT
Ferric Oxide Red1K09F3G675IACT
Chromic OxideX5Z09SU859IACT

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
Sunforgettable Total Protection Brush-On Shield SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencec77357f1-7ada-4325-86f7-5ee801610f422024-12-16WarningsExact identifier
ndc (package): 68078-027-03
ndc (package): 68078-027-02
ndc (package): 68078-027-01
ndc (product): 68078-027
ndc11 (package): 68078002703
ndc11 (package): 68078002702
ndc11 (package): 68078002701
spl id: b77c93ed-53fb-45b4-9aa7-a02e3a32f6d0
spl set id: c77357f1-7ada-4325-86f7-5ee801610f42

Reported adverse events (FAERS/openFDA)#

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