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LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50

LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50

Approved
Approval ID

33db89ac-2653-78f5-e063-6394a90af03d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 28, 2025

Manufacturers
FDA

BEL STAR SA

DUNS: 880160197

Products 1

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

AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14141-405
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2025
FDA Product Classification

INGREDIENTS (37)

CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATEInactive
Code: 255PIF62MS
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive
Code: 59Z907ZB69
Classification: IACT
LINALYL ACETATEInactive
Code: 5K47SSQ51G
Classification: IACT
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENESInactive
Code: 2JU6ZH6GRE
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
LINALOOL, (+)-Inactive
Code: F4VNO44C09
Classification: IACT
CAMPHOR (NATURAL)Inactive
Code: N20HL7Q941
Classification: IACT
CITRONELLOLInactive
Code: P01OUT964K
Classification: IACT
ETHYLHEXYL METHOXYCRYLENEInactive
Code: S3KFG6Q5X8
Classification: IACT
CITRUS AURANTIUM PEEL OILInactive
Code: 9TLV70SV6I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PINENEInactive
Code: 996299PUKB
Classification: IACT
CYCLOHEXASILOXANEInactive
Code: XHK3U310BA
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
OCTINOXATEActive
Quantity: 30 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
PHYSALIS ANGULATAInactive
Code: W4TKW9D5GG
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
POTASSIUM CETYL PHOSPHATEInactive
Code: 03KCY6P7UT
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
EICOSYL POVIDONEInactive
Code: XQQ9MKE2BJ
Classification: IACT
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERInactive
Code: WB5K9Y35Y9
Classification: IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive
Code: 8Z5ZAL5H3V
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive
Code: 5041RX63GN
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB

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LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 - FDA Drug Approval Details