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 109 of 198 · 3,946 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GoodSense Hemorrhoidal Pain Relief	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Perrigo Direct, Inc	2e5f699d-45e8-6451-e063-6394a90a8ad8	2025-07-20	Warnings	Exact identifier unii: 4T6H12BN9U unii: PDC6A3C0OX
Medicated Peppermint Lip Balm	DIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATE	Blistex Inc	5d48a6fa-ddce-47c3-9b09-1f3abb695017	2025-07-18	Warnings	Exact identifier unii: 4Y5P7MUD51
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc	3a39ac31-85c9-5e04-e063-6394a90aa537	2025-07-18	Warnings	Exact identifier unii: 4Y5P7MUD51
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3afeda-f235-eac2-e063-6294a90a5a93	2025-07-18	Warnings	Exact identifier unii: 4Y5P7MUD51
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3b5f56-aa36-01c7-e063-6294a90a6d62	2025-07-18	Warnings	Exact identifier unii: 4Y5P7MUD51
SilkTears	GLYCERIN OPHTHALMIC SOLUTION	SilkTears	3866e2c1-051b-0b01-e063-6394a90af5cf	2025-07-16	Warnings	Exact identifier unii: PDC6A3C0OX
Rena-Chord	HOMEOPATHIC LIQUID	Energetix Corporation	4071f90a-8a28-4338-810b-c9b18cf32f87	2025-07-15	Warnings	Exact identifier unii: LMI26O6933
Amarte ULTRA VEIL Daily	SUNSCREEN	Amarte USA LLC	39e9ca98-d0e8-6b8f-e063-6394a90aa366	2025-07-15	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
Amarte ULTRA VEIL BB Fair	SUNSCREEN	Amarte USA LLC	39e87950-4103-c2eb-e063-6394a90a0552	2025-07-15	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4Y5P7MUD51
Basin Vanilla SPF 30 Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	4a8e7be0-97a6-ada5-e063-6294a90ae25a	2025-07-14	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 4Y5P7MUD51
Nikzon Hemorrhoidal	GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE	Genomma Lab USA	8f9a9939-2c99-489f-b597-9a51ec2684f9	2025-07-14	Warnings	Exact identifier unii: 4T6H12BN9U unii: PDC6A3C0OX
Neosporin Lip Health Overnight Renewal Therapy	PETROLATUM	Kenvue Brands LLC	0da54fe1-c99f-4a2d-9ee5-2dc24005096c	2025-07-10	Warnings	Exact identifier unii: 4T6H12BN9U
Venofye Orchard Bee Brilliance SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE	Innovation Brands Inc.	7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe	2025-07-10	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 4Y5P7MUD51
Touch Anti-Aging SPF 30 Moisturizer	ZINC OXIDE, OCTINOXATE, AND OCTISALATE	Diractions Capital LLC	47ce948e-5848-43a1-880e-aeb78e9ad1b3	2025-07-10	Warnings	Exact identifier unii: 4Y5P7MUD51
COCOA BUTTER PETROLEUM jelly	PETROLATUM	Savvy Care & Cosmetics Pvt. Ltd.	397d13f1-3b86-3c76-e063-6394a90a0f24	2025-07-09	Warnings	Exact identifier unii: 4T6H12BN9U
Maximum Strength Hemorrhoidal Cream with Aloe	GLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUM	Chain Drug Marketing Association	396ea654-8be1-591a-e063-6294a90a11e2	2025-07-08	Warnings	Exact identifier unii: PDC6A3C0OX
Desitin Multi-Purpose Healing	PETROLATUM	Kenvue Brands LLC	30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab	2025-07-07	Warnings	Exact identifier unii: 4T6H12BN9U
24K Skin Tone Moisturizer SPF 30	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	b4f37f69-c61d-40c6-86cc-95d041b4d1b5	2025-07-07	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 4Y5P7MUD51
Vine Vera Resveratrol Cabernet Replenishing Moisture	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	c48a7346-3971-4946-b527-a5549a98e246	2025-07-07	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 4Y5P7MUD51
Creamy Petroleum	PETROLATUM	Savvy Care & Cosmetics Pvt Ltd	3916daee-f8d2-e3f0-e063-6294a90a3883	2025-07-04	Warnings	Exact identifier unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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