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 136 of 195 · 3,884 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MISSHA M Perfect Cover BB No 13	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	95846b5e-5b72-26bc-e053-2a95a90ae0f7	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
MISSHA M Perfect Cover BB No 21	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	9585d3d2-806c-36e3-e053-2a95a90a28fa	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
MISSHA M Perfect Cover BB SPF42 No21	OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	3d196cf3-eddd-21d7-e054-00144ff88e88	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
MISSHA M Perfect Cover BB No 23	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	6a81522e-f4d9-4013-8563-f50f01ff6326	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
Milani Prime Protect SPF 30 Face Primer	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	The Milani Group, Inc.	d557d554-5161-482c-bd78-7721c7dc9a6e	2024-12-04	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 4Y5P7MUD51
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100	TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S A	e4bb5a32-c5dc-86d5-e053-2a95a90a4938	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	ec688073-6577-6cf9-e053-2a95a90a631d	2024-12-04	Warnings	Exact identifier unii: 4T6H12BN9U
Burts Bees Rapid Rescue Cold Sore Treatment	CAMPHOR, GLYCERIN	Burts Bees	9f89735d-205f-4d3e-a1e1-ecc96284fe98	2024-12-03	Warnings	Exact identifier unii: PDC6A3C0OX
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber	ZINC OXIDE, TITANIUM DIOXIDE	Alumier Labs	ba864a08-e66d-d286-e053-2995a90a1854	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	2874e531-d647-339c-e063-6394a90ac86f	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration Tinted Moisturizing Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a951ebe7-7786-38ef-e053-2995a90a70e3	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Expanscience Laboratories d/b/a Mustela	beec926c-35a5-1901-e053-2a95a90ad043	2024-12-02	Warnings	Exact identifier unii: 15FIX9V2JP
ZINC OXIDE	ZINC OXIDE	VIVE HEALTH LLC	284dbf6a-6fa2-742b-e063-6394a90afdfd	2024-12-02	Warnings	Exact identifier unii: 4T6H12BN9U
Maximum Strength Cold Sore Treatment	CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM	Meijer Distribution Inc	9220772c-b3b7-4855-e053-2a95a90a94f6	2024-11-27	Warnings	Exact identifier unii: 4T6H12BN9U
Orajel Cold Sore Moisturelock	BENZOCAINE	Church & Dwight Co., Inc.	3761c7b3-053b-0f50-e054-00144ff88e88	2024-11-26	Warnings	Exact identifier unii: 4T6H12BN9U
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	95d657e5-cf89-48dd-a12e-f9664b131eb9	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	33f42840-92f8-4fa1-86e9-ec0a06d637de	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	20785934-e534-4ea5-8c15-f9669b042153	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e4464601-a9ec-413b-a883-9efe61f2f5b2	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5e7c879c-1e5c-4614-bec1-d363978c3b0d	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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