FDA.reportPublic FDA data

Rodan and Fields Plumping Lip SPF 28 Sunscreen

Product NDC
14222-3000
11-digit product format
142223000
Labeler code
14222
Product ID
14222-3000_34344639-3688-4926-ae5a-8bcdf7c568ec
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Zinc Oxide
Dosage form
OIL
Route
TOPICAL
Labeler
Rodan & Fields
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-16
Substance
OCTINOXATE; ZINC OXIDE
Active strength
7.4; 7 g/100mL; g/100mL
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
Rodan and Fields Plumping Lip SPF 28 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.4 g/100mL
ZINC OXIDE7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal 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
edf05ccc-4299-48d5-8f8e-01255eca11c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-3000-1Rodan and Fields Plumping Lip SPF 28 Sunscreen5 mL in 1 TUBEOIL52
14222-3000-1Rodan and Fields Plumping Lip SPF 28 Sunscreen1 in 1 BOXOIL12
14222-3000-2Rodan and Fields Plumping Lip SPF 28 Sunscreen5 mL in 1 TUBEOIL52
14222-3000-2Rodan and Fields Plumping Lip SPF 28 Sunscreen1 in 1 BOXOIL12
14222-3000-3Rodan and Fields Plumping Lip SPF 28 Sunscreen5 mL in 1 TUBEOIL52
14222-3000-3Rodan and Fields Plumping Lip SPF 28 Sunscreen1 in 1 BOXOIL12
14222-3000-4Rodan and Fields Plumping Lip SPF 28 Sunscreen5 mL in 1 TUBEOIL52
14222-3000-4Rodan and Fields Plumping Lip SPF 28 Sunscreen1 in 1 BOXOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-3000RODAN AND FIELDS PLUMPING LIP SPF 28 SUNSCREEN (OCTINOXATE, ZINC OXIDE) OIL [RODAN & FIELDS]2Current NDC, 8 package rows20241212_edf05ccc-4299-48d5-8f8e-01255eca11c2.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 122 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Mineral Zinc Oxide SPF 40ZINC OXIDESpalina LLC.35aa74c5-1bb3-9814-e063-6294a90a69992025-12-15Exact identifier
application number: M020
Mineral Tinted SPF40 with ceramidesZINC OXIDESpalina LLC.35ac3bd1-a4c1-5078-e063-6394a90afdc82025-12-15Exact identifier
application number: M020
Suns Out Funs OutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC46040acf-512e-c867-e063-6294a90ac2202025-12-15WarningsExact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3981c878-826d-f685-e063-6294a90acb242025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
application number: M020
Ultra Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc833d-f231-5f52-e063-6394a90a37a62025-12-15Exact identifier
application number: M020
Ultra Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc4586-5e62-c9e7-e063-6294a90a276b2025-12-15Exact identifier
application number: M020
20Percent Zinc Total ProtectionZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bcaee1-001b-82da-e063-6394a90a4a0f2025-12-15Exact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
application number: M020
Protection E And C Lightly TintedZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bce44e-d9f1-9279-e063-6394a90a64532025-12-15Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
application number: M020
Glow ShieldZINC OXIDEKristina Lerner35be8766-1352-8967-e063-6294a90a896a2025-12-15Exact identifier
application number: M020
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386bb911-9dbb-30fb-e063-6394a90a5e4d2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c0261-68f9-6f27-e063-6294a90a82092025-12-15Exact identifier
application number: M020
PURE Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c320b-22c3-7d35-e063-6394a90a4e0b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
application number: M020
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14222-3000-1142223000011 TUBE in 1 BOX (14222-3000-1) / 5 mL in 1 TUBE1 tube2024-05-16NoNoCurrent
14222-3000-2142223000021 TUBE in 1 BOX (14222-3000-2) / 5 mL in 1 TUBE1 tube2024-05-16NoNoCurrent
14222-3000-3142223000031 TUBE in 1 BOX (14222-3000-3) / 5 mL in 1 TUBE1 tube2024-05-16NoNoCurrent
14222-3000-4142223000041 TUBE in 1 BOX (14222-3000-4) / 5 mL in 1 TUBE1 tube2024-05-16NoNoCurrent