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
LabelManufacturerEffective dateType
Octinoxate - Ventura Corporation (San Juan, P.R) | Bel Star S.A. (Colombia)Ventura Corporation (San Juan, P.R) | Bel Star S.A. (Colombia)2011-09-20HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-059-022025-03-31C16284748780-1960f7f55-bf57-8e05-e053-dbdaa90a074aEsika Ultra-Softening Lipstick FPS 15
13537-059-022019-10-29C16284748780-1960f7f55-bf57-8e05-e053-dbdaa90a074aEsika Ultra-Softening Lipstick FPS 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
OctinoxateACTIVE MOIETY4Y5P7MUD51ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
OxybenzoneACTIVE MOIETY95OOS7VE0YESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
.beta.-sitosterolINACTIVE INGREDIENTS347WMO6M4ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
candelilla waxINACTIVE INGREDIENTWL0328HX19ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
castor oilINACTIVE INGREDIENTD5340Y2I9GESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
cetearyl glucosideINACTIVE INGREDIENT09FUA47KNAESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
cholesterolINACTIVE INGREDIENT97C5T2UQ7JESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
cochinealINACTIVE INGREDIENTTZ8Z31B35MESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
D&C red no. 21INACTIVE INGREDIENT08744Z6JNYESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
D&C red no. 27INACTIVE INGREDIENT2LRS185U6KESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
D&C red no. 30INACTIVE INGREDIENT2S42T2808BESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
D&C red no. 7INACTIVE INGREDIENTECW0LZ41X8ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
ethylhexyl palmitateINACTIVE INGREDIENT2865993309ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1MESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
glyceryl isostearateINACTIVE INGREDIENTHYE7O27HAOESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR7ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
isostearyl alcoholINACTIVE INGREDIENTQ613OCQ44YESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
micaINACTIVE INGREDIENTV8A1AW0880ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
octyldodecanolINACTIVE INGREDIENT461N1O614YESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
shea butterINACTIVE INGREDIENTK49155WL9YESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
talcINACTIVE INGREDIENT7SEV7J4R1UESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VESIKA (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 140 of 195 · 3,884 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd4f30d95-4a3f-49ad-817e-faa86fca50182024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
unii: 15FIX9V2JP
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
unii: 15FIX9V2JP
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
unii: 15FIX9V2JP
Vivant Day Treatment SPF 15OCTINOXATE 7.50% OCTISALATE 5.00%Vivant Pharmaceuticals, LLC10a95d0a-366f-0611-e063-6294a90abb442024-11-05WarningsExact identifier
unii: 4Y5P7MUD51
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
unii: PDC6A3C0OX
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
unii: PDC6A3C0OX
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.8c8d63b6-763a-44f8-87ef-e83a89ec37762024-10-31WarningsExact identifier
unii: LMI26O6933
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: LMI26O6933
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: Z8IX2SC1OH
unii: 15FIX9V2JP
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENECOSMAX USA, INC.2596a17e-4042-3544-e063-6294a90aa4c92024-10-29WarningsExact identifier
unii: 4Y5P7MUD51
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
unii: 15FIX9V2JP
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBel Star S.A.eea17271-e8c8-ab21-e053-2995a90a2fcc2024-10-28WarningsExact identifier
unii: 4Y5P7MUD51
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.0b782198-58e7-5343-e063-6294a90a37132024-10-28WarningsExact identifier
unii: 4Y5P7MUD51
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBAY BELLE LABS259653e7-dfe0-44a2-e063-6294a90a416d2024-10-28WarningsExact identifier
unii: 4Y5P7MUD51
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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