FDA.reportPublic FDA data

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 212 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TALLOW SUNSCREENNON-NANO ZINC OXIDEFOUNDATION COMMERCE INC363e38bf-b4b4-dcc4-e063-6294a90a5d2f2025-05-28WarningsExact identifier
application number: M020
CoreTex SunX 50 FacestickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc364989ea-c93b-d404-e063-6294a90abd092025-05-28WarningsExact identifier
application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30OCTINOXATE, ZINC OXIDESOLVADERM LLC86dbd8c3-e95a-49a8-afe6-ff9d985e28ba2025-05-27WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350b4cce-1627-5b8f-e063-6294a90aa6bf2025-05-26WarningsExact identifier
application number: M020
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEONESKIN INC.35d57d3f-376c-2307-e063-6294a90adf512025-05-23WarningsExact identifier
application number: M020
Oathology Inzincable Lip Balm SPF 35ZINC OXIDESKINOATH LLC289a5492-af57-42e5-82af-3f1e4b369d682025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, LightZINC OXIDEALLI LLC3cb4459b-1776-414a-b5c4-0ffb9f1df7662025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, DarkZINC OXIDEALLI LLC81633684-f9ac-45cb-8a3e-f0c30b229a822025-05-22WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.35c106b6-9a80-01e3-e063-6294a90abc352025-05-22WarningsExact identifier
application number: M020
COSRXAIRY-LIGHT CLEAR SUNCREEN STICKCOSRX inc.313b1a73-8863-c458-e063-6394a90a01d62025-05-20WarningsExact identifier
application number: M020
Melan Antioxidant Body Mist Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMELAN INC.f627b17f-d2dc-47bd-b865-08995995e8612025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.63e078a3-d5df-4458-a745-e306d734e6be2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.90531e8f-15c6-49ac-96a4-3bdfab2bfd9b2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.28db9f44-780f-4cd5-940e-3ee779f382472025-05-20WarningsExact identifier
application number: M020
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
application number: M020
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
application number: M020
Coola Clear California SummersOCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATECOOLA, LLC358009c4-492d-ac03-e063-6294a90af2272025-05-19WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEONESKIN INC.3581f578-e19e-9ace-e063-6294a90acc342025-05-19WarningsExact 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