FDA.reportPublic FDA data

RODAN and FIELDS UNBLEMISH

Product NDC
54111-122
11-digit product format
541110122
Labeler code
54111
Product ID
54111-122_b839d61b-5844-4269-b838-ad6ece3e8064
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-03-05
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
.21; 1.425 g/30mL; g/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RODAN and FIELDS UNBLEMISH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE.21 g/30mL
ZINC OXIDE1.425 g/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-122-502023-12-19C16284748780-1d6a99b39-d039-a426-e053-dadaa90af4c22b3b6b62-364f-4aba-8024-3a73752b4c56
54111-122-502022-01-28C16284748780-1d6a99b39-d039-a426-e053-dadaa90af4c22b3b6b62-364f-4aba-8024-3a73752b4c56

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-122-50RODAN and FIELDS UNBLEMISH30 mL in 1 TUBELOTION304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
AZELAIC ACIDINACTIVE INGREDIENTF2VW3D43YTRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
BOERHAVIA DIFFUSA ROOTINACTIVE INGREDIENTKR0SR09KYLRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RARODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438URODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ERODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CETETH-10 PHOSPHATEINACTIVE INGREDIENT4E05O5N49GRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
DIHEXADECYL PHOSPHATEINACTIVE INGREDIENT2V6E5WN99NRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ORODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LURODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
MASOPROCOLINACTIVE INGREDIENT7BO8G1BYQURODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFARODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
PEG-60 ALMOND GLYCERIDESINACTIVE INGREDIENT4Y0E651N0FRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)INACTIVE INGREDIENTH5BJH23Z9ARODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
SQUALANEINACTIVE INGREDIENTGW89575KF9RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
TROPOLONEINACTIVE INGREDIENT7L6DL16P1TRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RRODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEERODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-122RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]4Current NDC, Legacy NDC, 1 package rows20241228_2b3b6b62-364f-4aba-8024-3a73752b4c56.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-122-505411101225030 mL in 1 TUBE (54111-122-50) 30 ml2010-03-050000-00-00NoNoCurrent