NDC 13537-059-01 - ESIKA Ultra Softening SPF 15

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 13537-059
Requested NDC: 13537-059-01
Package NDCs from labels: 13537-059-01, 13537-059-02
Manufacturer: Ventura Corporation (San Juan, P.R) | Bel Star S.A. (Colombia)
Effective date: 2011-09-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Octinoxate - Ventura Corporation (San Juan, P.R) \| Bel Star S.A. (Colombia)	Ventura Corporation (San Juan, P.R) \| Bel Star S.A. (Colombia)	2011-09-20	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-059-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-059-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
.beta.-sitosterol	INACTIVE INGREDIENT	S347WMO6M4	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
candelilla wax	INACTIVE INGREDIENT	WL0328HX19	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
cetearyl glucoside	INACTIVE INGREDIENT	09FUA47KNA	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
cholesterol	INACTIVE INGREDIENT	97C5T2UQ7J	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
cochineal	INACTIVE INGREDIENT	TZ8Z31B35M	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
D&C red no. 21	INACTIVE INGREDIENT	08744Z6JNY	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
D&C red no. 27	INACTIVE INGREDIENT	2LRS185U6K	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
D&C red no. 30	INACTIVE INGREDIENT	2S42T2808B	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
D&C red no. 7	INACTIVE INGREDIENT	ECW0LZ41X8	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
ethylhexyl palmitate	INACTIVE INGREDIENT	2865993309	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
FD&C yellow no. 5	INACTIVE INGREDIENT	I753WB2F1M	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
glyceryl isostearate	INACTIVE INGREDIENT	HYE7O27HAO	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
high density polyethylene	INACTIVE INGREDIENT	UG00KM4WR7	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
isostearyl alcohol	INACTIVE INGREDIENT	Q613OCQ44Y	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
medium-chain triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
mica	INACTIVE INGREDIENT	V8A1AW0880	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
microcrystalline wax	INACTIVE INGREDIENT	XOF597Q3KY	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
octyldodecanol	INACTIVE INGREDIENT	461N1O614Y	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1
yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 152 of 194 · 3,871 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bunnies Bum Soothing Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	FloCal Distributors LLC	1c81582c-7ece-182f-e063-6294a90a8fbc	2024-07-05	Warnings	Exact identifier unii: 4T6H12BN9U unii: PDC6A3C0OX
Zenibell Snail Intensive	GLYCERIN	MISOCOS	97747267-26f1-d06f-e053-2a95a90ab087	2024-07-04	Warnings	Exact identifier unii: PDC6A3C0OX
Lip Medex Lip Balm	PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	988f97e8-a59f-4bc0-9d71-60607364a686	2024-07-01	Warnings	Exact identifier unii: 4T6H12BN9U
Metals	ALUMINA, AURUM METALLICUM, CARBO VEGETABILIS, CAUSTICUM, CYSTEINUM, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLATINUM METALLICUM, STANNUM METALLICUM, STILLINGIA SYLVATICA, TELLURIUM METALLICUM, X-RAY	Liddell Laboratories, Inc.	daa89e0d-1dd8-45eb-9f9b-0029fdcfecee	2024-07-01	Warnings	Exact identifier unii: LMI26O6933
Silk Line Silk Day Cream SPF 15	OCTINOXATE, OCTOCRYLENE, OCTISALATE	Biocosmetica Exel Argentina SRL	b2965aba-fcde-16f6-e053-2995a90aa9d8	2024-06-30	Warnings	Exact identifier unii: 4Y5P7MUD51
Exel Clarifying Line SPF 50	OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE	Exelencia importers	0d6d4098-4121-477e-b404-3ab18628ed68	2024-06-30	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 15FIX9V2JP unii: 4Y5P7MUD51
Silk Line Silk Day Cream SPF 15	OCTINOXATE, OCTOCRYLENE, OCTISALATE	Exelencia Importers, Corp.	b2d35086-748b-55d0-e053-2995a90a1898	2024-06-30	Warnings	Exact identifier unii: 4Y5P7MUD51
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	28c51c59-dbfb-45e5-b536-6e5d5c5560d6	2024-06-28	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry Skin	OCTINOXATE	L'Oreal USA Products Inc	90326e7e-8fdf-4221-afc0-208774d8ba6f	2024-06-28	Warnings	Exact identifier unii: 4Y5P7MUD51
Lip Medex Cherry	PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8	2024-06-28	Warnings	Exact identifier unii: 4T6H12BN9U
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	f6457973-3718-44cd-a764-de0b089d4eee	2024-06-28	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	8598d56b-adcd-48e8-b6fc-77bc934009c7	2024-06-27	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5	OCTINOXATE	L'Oreal USA Products Inc	12ec5a93-8c24-4ac9-94df-910dd8137e00	2024-06-27	Warnings	Exact identifier unii: 4Y5P7MUD51
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	be2a83fb-e4f8-4313-b5bd-150f351fb345	2024-06-26	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	066a0951-2e7e-40c0-8035-4d708a32f16c	2024-06-26	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
Astonea Vitamin A and D	WHITE PETROLATUM	ASTONEA LABS PRIVATE LIMITED	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2024-06-25	Warnings	Exact identifier unii: 4T6H12BN9U
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	66a91768-6012-485a-b569-a293ea6d4880	2024-06-24	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	43539766-2e70-4b42-b64b-1d30367b2eb9	2024-06-24	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE	SICOS ET CIE	3b49a970-653b-4256-b2d3-4e065db63849	2024-06-24	Warnings	Exact identifier unii: 4Y5P7MUD51
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE	L'Oreal USA Products Inc.	1b851e19-add0-437b-86e4-e88a10a1e774	2024-06-24	Warnings	Exact identifier unii: 4Y5P7MUD51

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.