Revlon Colorstay Preo and Protect Primer

Product NDC
10967-652
11-digit product format
109670652
Labeler code
10967
Product ID
10967-652_2a9692e8-80b4-15a8-e063-6394a90aa10d
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide, Octinoxate Primer
Dosage form
LIQUID
Route
TOPICAL
Labeler
Revlon Consumer Products Corp
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
Substance
ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE
Active strength
9; 7.5; 3.6 mg/mL; 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
Revlon Colorstay Preo and Protect Primer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE9 mg/mL
OCTINOXATE7.5 mg/mL
TITANIUM DIOXIDE3.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8eebf23e-7fce-dfc0-e053-2995a90ae322Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-652-11Revlon Colorstay Preo and Protect Primer26.6 mL in 1 BOTTLE, PLASTICLIQUID26.62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-652REVLON COLORSTAY PREO AND PROTECT PRIMER (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMER) LIQUID [REVLON CONSUMER PRODUCTS CORP]2Current NDC, Legacy NDC, 1 package rows20250101_8eebf23e-7fce-dfc0-e053-2995a90ae322.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 262 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 21ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9585d3d2-806c-36e3-e053-2a95a90a28fa2024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No21OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3d196cf3-eddd-21d7-e054-00144ff88e882024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 23ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.6a81522e-f4d9-4013-8563-f50f01ff63262024-12-04WarningsExact identifier
application number: M020
Milani Prime Protect SPF 30 Face PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONEThe Milani Group, Inc.d557d554-5161-482c-bd78-7721c7dc9a6e2024-12-04WarningsExact identifier
application number: M020
Pipette Diaper RashZINC OXIDEAmyris, Incef5ea6f5-0126-47de-9bee-9070c5f6112b2024-12-04WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc81a889b8-0719-40c9-b8d4-d9220747ce492024-12-04WarningsExact identifier
application number: M020
Bright-eyed 100% mineral Eye Cream Broad Spectrum Sunscreen SPF 40ZINC OXIDESupergoop, LLC971ac413-5e69-7553-e053-2995a90a41682024-12-04WarningsExact identifier
application number: M020
PLAY Antioxidant Body Mist SPF 50 With Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9c5c0608-3f42-6640-e053-2a95a90a50862024-12-04WarningsExact identifier
application number: M020
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S Ae4bb5a32-c5dc-86d5-e053-2a95a90a49382024-12-04WarningsExact identifier
application number: M020
Burts Bees Firming Day SPF30ZINC OXIDEBurts Beesf028ffea-184b-46db-9e48-dab4a535bf002024-12-03WarningsExact identifier
application number: M020
Burts Bees Calming Day SPF30ZINC OXIDEBurts Beese406e6ba-fa6d-452d-bc29-404e2f8fcf3e2024-12-03WarningsExact identifier
application number: M020
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen AmberZINC OXIDE, TITANIUM DIOXIDEAlumier Labsba864a08-e66d-d286-e053-2995a90a18542024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs2874e531-d647-339c-e063-6394a90ac86f2024-12-03WarningsExact identifier
application number: M020
REEF SAFE Unscented SPF Mineral Sunscreen 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.286965aa-0961-0141-e063-6394a90aa3f02024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer Hydration Tinted Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa951ebe7-7786-38ef-e053-2995a90a70e32024-12-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10967-652-111096706521126.6 mL in 1 BOTTLE, PLASTIC (10967-652-11) 26.6 ml2019-01-010000-00-00NoNoCurrent