FDA.reportPublic FDA data

Brightening Primer SPF 20

Manufacturer
Colorescience
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:26:32

Label at a glance#

ProductBrightening Primer SPF 20
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 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 5.0%Sunscreen
Zinc Oxide 4.5%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 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, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Aqua/Water, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopherol Acetate, Mica, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Rice Protein, Dimethiconol, Avena Sativa (Oat) Kernel Protein, Spirulina Maxima Extract, Alumina, Silica, Jojoba Esters, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Lauroyl Lysine, Palmitoyl Tripeptide-5, Glycine Soja (Soybean) Oil, Tocopherol, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Limonene, Linalool, Beta Carotene (CI 40800).

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

BRIGHTENING
PRIMER

3-IN-1 FACE PRIMER

Illuminates skin tone
Revives dull looking skin
Extends makeup wear

20
Broad Spectrum
SPF 20 Sunscreen
PA+++

CHEMICAL-FREE ACTIVES | 100% MINERAL
WATER/SWEAT RESISTANT (40 MINUTES)

1 fl. oz. / 30 mL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-037-01Brightening Primer SPF 201 in 1 CARTONLIQUID13
68078-037-01Brightening Primer SPF 2030 mL in 1 BOTTLELIQUID303

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-03768078-037-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MICAV8A1AW0880IACT
JOJOBA OIL724GKU717MIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
OATZ6J799EAJKIACT
ARTHROSPIRA MAXIMA9K7IG15M0QIACT
ALUMINUM OXIDELMI26O6933IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
ALOE VERA LEAFZY81Z83H0XIACT
TEA TREE OILVIF565UC2GIACT
LAVENDER OILZBP1YXW0H8IACT
MANDARIN OILNJO720F72RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LAUROYL LYSINE113171Q70BIACT
PALMITOYL TRIPEPTIDE-52A3916MQHOIACT
SOYBEAN OIL241ATL177AIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM BENZOATEOJ245FE5EUIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BETA CAROTENE01YAE03M7JIACT
GERANIOLL837108USYIACT
LINALYL ACETATE5K47SSQ51GIACT
PENTYLENE GLYCOL50C1307PZGIACT
LAVANDIN OIL9RES347CKGIACT
HYDROLYZED RICE PROTEIN (ENZYMATIC; 2000 MW)J9JP2XE45MIACT

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
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
ndc (package): 68078-037-01
ndc (product): 68078-037
ndc11 (package): 68078003701
spl id: 9d8fd624-8d98-41b1-8228-60900e30592b
spl set id: a42d6761-47cd-4c9b-9656-64e37e065639

Reported adverse events (FAERS/openFDA)#

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