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 143 of 194 · 3,871 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Sunscreen SPF100 SPORT Broad Spectrum	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE	WAL-MART STORES INC	1ce4839b-f693-4653-8fe2-444df76eb83c	2024-10-16	Warnings	Exact identifier unii: 95OOS7VE0Y
Big Lots Soundbody SPF 70 Sun Defense	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	BIG LOTS STORES, INC.	db3ad809-d6c9-6c83-e053-2a95a90ac58b	2024-10-16	Warnings	Exact identifier unii: 95OOS7VE0Y
Equate Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	81ecb091-38da-4b3e-a0a1-b4986b97ee09	2024-10-16	Warnings	Exact identifier unii: 4T6H12BN9U
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	5c81d564-f786-46e1-af8b-f47521fbae60	2024-10-16	Warnings	Exact identifier unii: 4T6H12BN9U
topcare hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Topco Associates LLC	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	2024-10-16	Warnings	Exact identifier unii: 4T6H12BN9U
Basic Care Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Amazon.com Services LLC	fe675174-fc95-4dd7-bd39-c209c6ce0f6c	2024-10-16	Warnings	Exact identifier unii: 4T6H12BN9U
MINERAL BASED SPF 50 SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	THE KROGER COMPANY	a4e6936d-a76c-e8fd-e053-2995a90a965f	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	c51029f4-ede0-08ef-e053-2995a90aecaf	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f14f43e6-ee57-5495-e053-2a95a90a4011	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
TopCare Everyday Sport Continuous Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	f31ea60e-1f52-c55f-e053-2a95a90afe64	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	a5b06600-f2b0-6d9b-e053-2995a90a59f0	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	TOPCO ASSOCIATES LLC	bfe076fa-f21f-2c46-e053-2a95a90acee4	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	H.E.B.	c5279caf-3af9-d163-e053-2995a90a943b	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
HEB Solutions Sunscreen	SPORT SPF 100 LOTION	H.E.B	9e3ea66c-d6a0-49ca-a3c0-8175e0617453	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
H.E.B Solutions Sunscreen	ULTRA SPF 50 LOTION	H.E.B	12c76c72-4411-48d5-b79b-c58703bf1fdd	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
H.E.B Solutions Sunscreen	SPORT SPF 50 CONTINUOUS SPRAY	H.E.B	86ad5d30-f700-42a2-b810-dd2e3ed0f2d8	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
H.E.B Solutions Sunscreen	ULTRA SPF 100 CONTINUOUS SPRAY	H.E.B	be80244d-da6d-4d37-b228-4d3fac335caf	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
H.E.B Solutions Sunscreen	KIDS SPF 50 LOTION SPRAY	H.E.B	9b43c5d5-c279-4ae3-843e-1451f7324216	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
H.E.B Solutions Sunscreen	ULTRA SPF 50 CONTINUOUS SPRAY	H.E.B	2e183ba8-1b83-4211-bc08-dbdcee942ce9	2024-10-15	Warnings	Exact identifier unii: 95OOS7VE0Y
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Meijer Distribution Inc	fb170371-2e5d-43ca-a259-538a973ee3b8	2024-10-15	Warnings	Exact identifier unii: 4T6H12BN9U unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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