FDA.reportPublic FDA data

Brightening Primer SPF 20

Product NDC
68078-037
11-digit product format
680780037
Labeler code
68078
Product ID
68078-037_9d8fd624-8d98-41b1-8228-60900e30592b
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide and zinc oxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Colorescience
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
50; 4.5 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Brightening Primer SPF 20
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE50 mg/mL
ZINC OXIDE4.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a42d6761-47cd-4c9b-9656-64e37e065639Available on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-037BRIGHTENING PRIMER SPF 20 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]2Current NDC, Legacy NDC, 2 package rows20241215_a42d6761-47cd-4c9b-9656-64e37e065639.zip

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 43 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA SUN Body Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.12b64f66-0ec0-4dde-9446-4151ae001ae42026-04-15WarningsExact identifier
application number: M020
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEPML NYC, LLC396dc7c7-a5e1-e1b2-e063-6294a90a75472026-04-15WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
application number: M020
Chanvida Broad Spectrum BB CreamCHANVIDA BROAD SPECTRUM BB CREAMGuangzhou Ariel Biotech Co., Ltd.4f8ade09-4f7a-80bd-e063-6394a90a08432026-04-15WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEGold Inti Trade Corporation4f6dd01e-21ab-0aa3-e063-6394a90a51f82026-04-14WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERBEAUTY PIE U.S.A. INC.fdefb670-510c-9f1f-e053-6394a90a6a162026-04-14WarningsExact identifier
application number: M020
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40DAILY DOSE BIORETINOL MINERAL SPF 40PML NYC, LLC05574910-ddf9-b138-e063-6394a90adc8c2026-04-14WarningsExact identifier
application number: M020
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c0f2d9-3e2f-5358-e053-2995a90aeb842026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c2a37d-f52d-2fb0-e053-2a95a90a9bfa2026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c3b1ef-0eae-6ac7-e053-2a95a90ac1dc2026-04-14WarningsExact identifier
application number: M020
NATURIUM Dew-Glow Moisturizer SPF 50NATURIUM DEW-GLOW MOISTURIZER SPF 50PML NYC, LLC00c93b11-754e-701c-e063-6294a90a3b1d2026-04-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEPML NYC, LLC1c3489a6-5b98-2dc2-e063-6294a90a06952026-04-14WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONELongway Technology(Guangzhou)Co.,Ltd.4f2c83e4-e656-f81e-e063-6394a90a4c682026-04-11WarningsExact identifier
application number: M020
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
application number: M020
MIDHA Rice Daily Moisture Sun CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMIDHA Cosmetic Co.,Ltd.4b394107-7830-c2c6-e063-6294a90a07d92026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube DeepOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f15d5ba-6396-56bf-e063-6394a90adb062026-04-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68078-037-01680780037011 BOTTLE in 1 CARTON (68078-037-01) / 30 mL in 1 BOTTLE1 bottle2020-01-010000-00-00NoNoCurrent