LBEL DEFENSE 365 Daily Protective Facial SPF 50

Product NDC: 43596-0001
11-digit product format: 435960001
Labeler code: 43596
Product ID: 43596-0001_fb098a50-da0c-4609-9983-577a69896601
Type: HUMAN OTC DRUG
Nonproprietary name: HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: Ventura Corporation, LTD
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-03-25
Marketing end: 0000-00-00
Substance: HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43596-0001-0	2019-11-13	C162847	48780-1	97449f38-ba41-f6ea-e053-dbdaa90aa703	L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50
43596-0001-1	2019-11-13	C162847	48780-1	97449f38-ba41-f6ea-e053-dbdaa90aa703	L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50
43596-0001-2	2019-11-13	C162847	48780-1	97449f38-ba41-f6ea-e053-dbdaa90aa703	L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43596-0001-0	LBEL DEFENSE 365 Daily Protective Facial SPF 50	1 mL in 1 POUCH	LOTION	1	3
43596-0001-1	LBEL DEFENSE 365 Daily Protective Facial SPF 50	3 mL in 1 TUBE	LOTION	3	3
43596-0001-2	LBEL DEFENSE 365 Daily Protective Facial SPF 50	30 mL in 1 JAR	LOTION	30	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
AMBROSIA PERUVIANA LEAF	INACTIVE INGREDIENT	458F79CGBF	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
CETEARETH-12	INACTIVE INGREDIENT	7V4MR24V5P	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
FYTIC ACID	INACTIVE INGREDIENT	7IGF0S7R8I	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
HEDERA HELIX LEAF	INACTIVE INGREDIENT	ZP9XFG71A7	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
HELIANTHUS ANNUUS SEED WAX	INACTIVE INGREDIENT	42DG15CHXV	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
MICA	INACTIVE INGREDIENT	V8A1AW0880	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
PROPYLHEPTYL CAPRYLATE	INACTIVE INGREDIENT	991Z19V2OD	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43596-0001	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA CORPORATION, LTD]	3	Legacy NDC, 3 package rows	20120405_2bf70471-7221-4d6e-8ce6-2a81a54bdede.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43596-0001-0	43596000100	1 mL in 1 POUCH	1 ml	Historical
43596-0001-1	43596000101	3 mL in 1 TUBE	3 ml	Historical
43596-0001-2	43596000102	30 mL in 1 JAR	30 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50	Ventura Corporation, LTD \| MF Productions	2012-03-25	HUMAN OTC DRUG LABEL	3

LBEL DEFENSE 365 Daily Protective Facial SPF 50

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#