FDA.reportPublic FDA data

SPF 20 Loose Mineral Foundation

Manufacturer
Colorescience
Effective date
2021-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:59

Label at a glance#

ProductSPF 20 Loose Mineral Foundation
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: 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 18.6%Sunscreen
Zinc Oxide 5.9%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: 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, Methicone, Calcium Silicate, Dimethicone, Triethoxycaprylylsilane, Sodium Sulfate, Bismuth Oxychloride (CI 77163), Chromium Oxide Greens (CI 77288), 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

Manufactured by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

LOOSE
MINERAL
FOUNDATION

Breathable formula
Self-dispensing brush
Water resistant
(80 minutes)

20
Broad Spectrum
SPF 20
Sunscreen

Net Wt. 6 g / 0.21 oz.

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton
PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68078-000-012023-01-30C16284748780-1ba0f9c33-2d93-a910-e053-dadaa90a0b85SPF 20 Loose Mineral Foundation
68078-000-012021-12-28C16284748780-1ba0f9c33-2d93-a910-e053-dadaa90a0b85SPF 20 Loose Mineral Foundation
68078-000-012021-01-29C16284748780-1ba0f9c33-2d93-a910-e053-dadaa90a0b85SPF 20 Loose Mineral Foundation

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-000-01SPF 20 Loose Mineral Foundation6 g in 1 TUBE, WITH APPLICATORPOWDER63
68078-000-01SPF 20 Loose Mineral Foundation1 in 1 CARTONPOWDER13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-000SPF 20 LOOSE MINERAL FOUNDATION (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [COLORESCIENCE]3Legacy NDC, 2 package rows20211229_50ea65bc-80e7-4644-8cf3-d166cd2dfc04.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Bismuth OxychlorideINACTIVE INGREDIENT4ZR792I5871
Calcium SilicateINACTIVE INGREDIENTS4255P4G5M1
Chromic OxideINACTIVE INGREDIENTX5Z09SU8591
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Methicone (20 CST)INACTIVE INGREDIENT6777U11MKT1
MicaINACTIVE INGREDIENTV8A1AW08801
Sodium SulfateINACTIVE INGREDIENT0YPR65R21J1
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-00068078-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
MicaV8A1AW0880IACT
Bismuth Oxychloride4ZR792I587IACT
Dimethicone92RU3N3Y1OIACT
Methicone (20 CST)6777U11MKTIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Calcium SilicateS4255P4G5MIACT
Chromic OxideX5Z09SU859IACT
Sodium Sulfate0YPR65R21JIACT
Ferric Oxide Red1K09F3G675IACT
Ferrosoferric OxideXM0M87F357IACT
Ferric Oxide YellowEX438O2MRTIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 13 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium SulfateSODIUM SULFATE0YPR65R21JSOLUTION / OPHTHALMIC0.14 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
Calcium SilicateCALCIUM SILICATES4255P4G5MTABLET, FILM COATED / ORAL731 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium SulfateSODIUM SULFATE0YPR65R21JSOLUTION/ DROPS / OPHTHALMIC13 mgExact identifier — unii candidate
7 equally ranked IID candidates
Sodium SulfateSODIUM SULFATE0YPR65R21JTABLET, COATED / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
Calcium SilicateCALCIUM SILICATES4255P4G5MTABLET / ORAL146.13 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium SulfateSODIUM SULFATE0YPR65R21JTABLET / ORAL182 mgExact identifier — unii candidate
7 equally ranked IID candidates
Calcium SilicateCALCIUM SILICATES4255P4G5MTABLET, COATED / ORAL155 mgExact identifier — unii candidate
6 equally ranked IID candidates
Calcium SilicateCALCIUM SILICATES4255P4G5MCAPSULE / ORAL40 mgExact identifier — unii candidate
6 equally ranked IID candidates
Calcium SilicateCALCIUM SILICATES4255P4G5MTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
6 equally ranked IID candidates
Calcium SilicateCALCIUM SILICATES4255P4G5MTABLET, ORALLY DISINTEGRATING / ORAL600 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium SulfateSODIUM SULFATE0YPR65R21JSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Sodium SulfateSODIUM SULFATE0YPR65R21JTABLET, DELAYED RELEASE / ORAL16.24 mgExact identifier — unii candidate
7 equally ranked IID candidates
Sodium SulfateSODIUM SULFATE0YPR65R21JSOAP / TOPICAL0.05 %w/wExact identifier — unii candidate
7 equally ranked IID candidates

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
efeea22a-d55d-4fbf-939f-69ad4eca95b050ea65bc-80e7-4644-8cf3-d166cd2dfc042021-12-22WarningsExact identifier
spl id: efeea22a-d55d-4fbf-939f-69ad4eca95b0
spl set id: 50ea65bc-80e7-4644-8cf3-d166cd2dfc04

Reported adverse events (FAERS/openFDA)#

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