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 169 of 193 · 3,855 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Sheer Mineral Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	581e8289-1406-45b6-9786-753800665fad	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
UNIVERSAL ORIGINAL PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	47b8c720-ad1e-4ac7-ba73-872e409b38bf	2023-11-17	Warnings	Exact identifier unii: 4T6H12BN9U
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	1ac9ee69-339d-4426-b3bf-13e5386f1a9b	2023-11-17	Warnings	Exact identifier unii: 4T6H12BN9U
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a4cea12-7e00-d201-e063-6394a90a6691	2023-11-16	Warnings	Exact identifier unii: 15FIX9V2JP
SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE	CLINIQUE LABORATORIES LLC	fb841fd7-0c78-01a1-e053-6394a90a4382	2023-11-15	Warnings	Exact identifier unii: 4Y5P7MUD51
Beach Gypsy SPF-30	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	MJ Products Association, LLC	a518e048-5614-4b67-b6fa-e1f2e380f352	2023-11-15	Warnings	Exact identifier unii: 4Y5P7MUD51
Sea Star Sparkle SPF-50 MANGO-TANGO	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	MJ Products Association, LLC	1f4ea582-c4d5-4c0a-8fea-4eeb2fbb6327	2023-11-15	Warnings	Exact identifier unii: 4Y5P7MUD51
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	cf888bf3-6950-43aa-b4be-5a32961b4d96	2023-11-15	Warnings	Exact identifier unii: 4T6H12BN9U
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	b6e0ddb8-3761-482a-83d0-15d612d142eb	2023-11-15	Warnings	Exact identifier unii: 4T6H12BN9U
Max Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Peter Thomas Roth Labs, LLC	0980992c-6488-2fa1-e063-6294a90a41ea	2023-11-14	Warnings	Exact identifier unii: 15FIX9V2JP
In Transit Skin Defence	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE	THIS WORKS PRODUCTS LIMITED	c3425525-df4d-403b-ac7a-84067f030118	2023-11-14	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 4Y5P7MUD51
Perfect Legs Skin Protector SPF 30	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	THIS WORKS PRODUCTS LIMITED	e0c54af2-9ea4-4dec-9d48-104883950818	2023-11-14	Warnings	Exact identifier unii: 4Y5P7MUD51
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect Repellent	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BULLFROG BRANDS, LLC.	f70b39c6-9f40-f5c1-e053-6394a90a1d43	2023-11-13	Warnings	Exact identifier unii: 4Y5P7MUD51
Tropical Sands, SPF-50 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	493551d0-10a0-3d78-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	494a7886-d677-1648-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	ab691543-e37a-487a-912e-56d2e0e4d30a	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
LBri Pure nNatural Oil Free Moisturizer	OCTINOXATE, AVOBENZONE, OCTISALATE	L'Bri Health & Beauty	47f6ab9e-fa47-496a-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 4Y5P7MUD51
PURE HAVEN BODY SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Pure haven, LLC	6f298fcd-8a97-8f66-e053-2991aa0adb10	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunstation USA, LLC	499d366a-a7f1-6070-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Pure Haven Essentials	TITANIUM DIOXIDE, ZINC OXIDE	Pure Haven LLC	4bccc017-266d-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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