MedPath

CLn Body Moisturizer

CLn Body Moisturizer

Approved
Approval ID

2de3d68d-a540-d456-e063-6394a90a4b57

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 18, 2025

Manufacturers
FDA

TopMD Skin Care, Inc.

DUNS: 060946293

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Colloidal Oat Moisturizer

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69530-858
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Colloidal Oat Moisturizer
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 18, 2025
FDA Product Classification

INGREDIENTS (31)

LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
CERAMIDE NGInactive
Code: C04977SRJ5
Classification: IACT
PALMITOYL HEXAPEPTIDE-12Inactive
Code: HO4ZT5S86C
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
POLYACRYLATE-13Inactive
Code: FS2D4T67EA
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
GINGERInactive
Code: C5529G5JPQ
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
SORBITAN SESQUIISOSTEARATEInactive
Code: VU97D01BF9
Classification: IACT
HIPPOPHAE RHAMNOIDES SEED OILInactive
Code: T53SBG6741
Classification: IACT
TRIBEHENINInactive
Code: 8OC9U7TQZ0
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERSInactive
Code: 137SL7IL0Y
Classification: IACT
HYDROLYZED JOJOBA ESTERSInactive
Code: UDR641JW8W
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MAGNESIUM ASCORBYL PHOSPHATEInactive
Code: 0R822556M5
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
OATInactive
Code: Z6J799EAJK
Classification: IACT
POLYISOBUTYLENE (1000 MW)Inactive
Code: 5XB3A63Y52
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
OATMEALActive
Quantity: 2 g in 100 g
Code: 8PI54V663Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/15/2025

CLn Body Moisturizer 8 oz TUBE L24.BM08T2_06.17.24

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/15/2025

Uses

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/15/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/15/2025

Active Ingredients

2% Collodial Oatmeal

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/15/2025

Purpose

Skin Protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 2/15/2025

Warnings

For external use only.

When using this product

● avoid contact with eyes

Stop use and ask doctor if

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

Keep out of reach of children.

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

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 2/15/2025

Directions

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/15/2025

Other Information

For mild to moderate ezcema

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/15/2025

Inactive Ingredients

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

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CLn Body Moisturizer - FDA Drug Approval Details