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Softlips Oasis Pineapple Coconut

Drug Facts - Softlips Oasis Pineapple Coconut

Approved
Approval ID

c504463a-28bf-4161-875f-ef73520931c5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 2, 2025

Manufacturers
FDA

The Mentholatum Company

DUNS: 002105757

Products 1

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

dimethicone, oxybenzone, octinoxate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10742-8745
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
dimethicone, oxybenzone, octinoxate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 2, 2025
FDA Product Classification

INGREDIENTS (32)

CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
POLYGLYCERYL-6 DISTEARATEInactive
Code: Z35I17EQOP
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
POLYGLYCERYL-3 RICINOLEATEInactive
Code: MZQ63P0N0W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMERInactive
Code: 035MV9S1C3
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
PINEAPPLEInactive
Code: 2A88ZO081O
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
SAFFLOWER OILInactive
Code: 65UEH262IS
Classification: IACT
CETEARYL GLUCOSIDEInactive
Code: 09FUA47KNA
Classification: IACT
COCONUTInactive
Code: 3RT3536DHY
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
HYALURONIC ACIDInactive
Code: S270N0TRQY
Classification: IACT
MEADOWFOAM SEED OILInactive
Code: 412ZHA4T4Y
Classification: IACT
RACEMENTHOLInactive
Code: YS08XHA860
Classification: IACT
PHYMATOLITHON CALCAREUMInactive
Code: 6J1M3WA0ZK
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATEInactive
Code: 65954KGO9Q
Classification: IACT
PORPHYRA UMBILICALISInactive
Code: 14AN0J70WO
Classification: IACT
SILANETRIOLInactive
Code: E52D0J3TS5
Classification: IACT
SILYBUM MARIANUM SEED OILInactive
Code: NYY23HEN06
Classification: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZ
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
DIMETHICONEActive
Quantity: 20 mg in 1 g
Code: 92RU3N3Y1O
Classification: ACTIB
OCTINOXATEActive
Quantity: 75 mg in 1 g
Code: 4Y5P7MUD51
Classification: ACTIB
OXYBENZONEActive
Quantity: 40 mg in 1 g
Code: 95OOS7VE0Y
Classification: ACTIB

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Softlips Oasis Pineapple Coconut - FDA Drug Approval Details