FDA.reportPublic FDA data

CLn Body Moisturizer

Manufacturer
TopMD Skin Care, Inc. | Inspec Solutions LLC
Effective date
2025-06-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:23

Label at a glance#

ProductCLn Body Moisturizer
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

Temporarily protects and helps releive minor skin irritation and itching due to: ● rashes ● ezcema

Dosage and administration

● apply as needed or as directed by doctor ● for children under 2 years of age: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

2% Collodial Oatmeal

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps releive minor skin irritation and itching due to: ● rashes ● ezcema

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

● avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

● condition worsens ● symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

● apply as needed or as directed by doctor ● for children under 2 years of age: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

For mild to moderate ezcema

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propanediol, Dimethicone, Petrolatum, Glyceryl Stearate, Cetyl Alcohol, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Hydrolyzed Jojoba Esters, Tocopheryl Acetate, Bisabolol, Ethylhexylglycerin, Polyacrylate-13, Panthenol, C10-30 Cholesterol/Lanosterol Esters, Lactic Acid, Polyisobutene, Jojoba Esters, Disodium EDTA, Butyrospermum Parkii (Shea) Butter, Zingiber Officinale (Ginger) Root Extract, Avena Sativa (Oat) Kernel Extract, Polysorbate-20, C12-15 Alkyl Benzoate, Sorbitan Isooctadecanoate, Magnesium Ascorbyl Phosphate, Hippophae Ramnoides Oil, Tribenhenin, Ceramide NG, PEG-10 Phytosterol, Palmitoyl Hexapeptide-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLn Body Moisturizer 8 oz TUBE L24.BM08T2_06.17.24CLn Body Moisturizer 8 oz TUBE L24.BM08T2_06.17.24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN3
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD3
1189915colloidal oatmeal 2 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

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
69530-858-01CLn Body Moisturizer30 g in 1 TUBECREAM303
69530-858-08CLn Body Moisturizer240 g in 1 TUBECREAM2403

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69530-85869530-858-01, 69530-858-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTIC ACID33X04XA5ATIACT
CERAMIDE NGC04977SRJ5IACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BISABOLOL24WE03BX2TIACT
POLYACRYLATE-13FS2D4T67EAIACT
PANTHENOLWV9CM0O67ZIACT
GINGERC5529G5JPQIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
TRIBEHENIN8OC9U7TQZ0IACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
GLYCERYL STEARATE230OU9XXE4IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
HYDROLYZED JOJOBA ESTERSUDR641JW8WIACT
PETROLATUM4T6H12BN9UIACT
EDETATE DISODIUM7FLD91C86KIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
POLYSORBATE 207T1F30V5YHIACT
OATZ6J799EAJKIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
PROPANEDIOL5965N8W85TIACT
OATMEAL8PI54V663YACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
ndc (package): 69530-858-01
ndc (package): 69530-858-08
ndc (product): 69530-858
ndc11 (package): 69530085801
ndc11 (package): 69530085808
spl id: 37d8adfd-a657-38d3-e063-6394a90aec43
spl set id: 2de3d68d-a540-d456-e063-6394a90a4b57

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.