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 90 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION207e2035-5f31-4745-a801-b386b040b7382026-01-05WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1OCTINOXATESHISEIDO AMERICAS CORPORATION8a9294c2-3933-4f9c-b7e6-1f446f441a162026-01-05WarningsExact identifier
application number: M020
Shiseido Future Solution LX Total ProtectiveAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION6de17911-4bce-46c9-906b-07d899a36ceb2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
application number: M020
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONb2b55a7a-1f68-429d-ba70-5bb6c7e0d8d32026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUDZINC OXIDEKao USA Inc.26cf1320-aae5-2ea0-e063-6394a90a3be22026-01-05WarningsExact identifier
application number: M020
OZE SUN BONDIZINC OXIDE SUNSCREENVEGANIC SKN LIMITED47b1aae6-0b86-7d48-e063-6294a90a9ece2026-01-05WarningsExact identifier
application number: M020
Hybrid SPF SPF 30OCTOCRYLENE, OCTISALATE, ZINC OXIDETopiderm, Inc.5c99f98c-025c-4886-824f-af968033baf42026-01-05WarningsExact identifier
application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
application number: M020
VEAKSON BEEF TALLOW SUNSCREENZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACIDGuangdong Aimu Biological Technology Co., Ltd473c241a-1258-1680-e063-6394a90a7d982026-01-04WarningsExact identifier
application number: M020
HYDRATING SUNSCREENHYDRATING SUNSCREENGuangzhou Yapeng Refinement Chemical Co., Ltd.19a3687b-32b0-7c83-e063-6294a90aaf812026-01-04WarningsExact 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