Blue Lizard Sport SPF 50 Sunscreen
Blue Lizard Sport SPF 50 Sunscreen
Approved
Approval ID
2f3844d8-0367-aad9-e063-6294a90a1fce
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 28, 2025
Manufacturers
FDA
Crown Laboratories
DUNS: 079035945
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Titanium Dioxide and Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0316-2078
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Titanium Dioxide and Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 28, 2025
FDA Product Classification
INGREDIENTS (33)
ZINC GLUCONATEInactive
Code: U6WSN5SQ1Z
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
MAGNESIUM ASPARTATEInactive
Code: R17X820ROL
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)Inactive
Code: 035JKJ76MT
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5
Classification: IACT
METHYL GLUCOSE DIOLEATEInactive
Code: FA9KFJ4Z6P
Classification: IACT
OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883T
Classification: IACT
PEG-7 HYDROGENATED CASTOR OILInactive
Code: WE09129TH5
Classification: IACT
POLYGLYCERYL-4 ISOSTEARATEInactive
Code: 820DPX33S7
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 89.6 mg in 1 mL
Code: 15FIX9V2JP
Classification: ACTIB
ZINC OXIDEActive
Quantity: 112 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
CETYL DIMETHICONE 25Inactive
Code: U4AS1BW4ZB
Classification: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
COPPER GLUCONATEInactive
Code: RV823G6G67
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ALUMINUM STEARATEInactive
Code: U6XF9NP8HM
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
HEXYL LAURATEInactive
Code: 4CG9F9W01Q
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)Inactive
Code: AG75W62QYU
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/5/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 12/5/2024
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/5/2024
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 12/5/2024
WARNINGS SECTION
LOINC: 34071-1Updated: 12/5/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/5/2024
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 12/5/2024
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 12/5/2024
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 12/5/2024