FDA.reportPublic FDA data

NDC 13537-348-01 - ESIKA Maximum Color SPF 18

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
13537-348
Requested NDC
13537-348-01
Package NDCs from labels
13537-348-01, 13537-348-02
Manufacturer
Ventura Corporation (San Juan, P.R) | Bel Star S.A. (Colombia)
Effective date
2011-05-18
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)2011-05-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-348-022025-05-06C16284748780-1960f7f55-d112-8e05-e053-dbdaa90a074aēsika Maximum Color Lipstick SPF 18
13537-348-022019-10-29C16284748780-1960f7f55-d112-8e05-e053-dbdaa90a074aēsika Maximum Color Lipstick SPF 18

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
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
butylparabenINACTIVE INGREDIENT3QPI1U3FV8ESIKA (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
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. 28INACTIVE INGREDIENT767IP0Y5NHESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
d&c red no. 6INACTIVE INGREDIENT481744AI4OESIKA (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
ethylparabenINACTIVE INGREDIENT14255EXE39ESIKA (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
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4THESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
isobutylparabenINACTIVE INGREDIENT0QQJ25X58GESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
isononyl isononanoateINACTIVE INGREDIENTS4V5BS6GCXESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TESIKA (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
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
propylene carbonateINACTIVE INGREDIENT8D08K3S51EESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHESIKA (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
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
starch, cornINACTIVE INGREDIENTO8232NY3SJESIKA (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
triethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08EESIKA (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION (SAN JUAN, P.R)]1
waterINACTIVE INGREDIENT059QF0KO0RESIKA (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 57 of 216 · 4,315 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
unii: 1K09F3G675
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
Coppertone Defend and ClearOCTINOXATE, OCTISALATE, ZINC OXIDEBeiersdorf Incbaaec6a9-2c60-2d11-e053-2a95a90abca72025-12-31WarningsExact identifier
unii: 4Y5P7MUD51
Coppertone Kids Tear Free Mineral Sunscreen SPF 50OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%Beiersdorf Incc054fd86-b0d9-24fc-e053-2a95a90aea2c2025-12-31WarningsExact identifier
unii: 4Y5P7MUD51
Coppertone Kids Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc0552256-d8cb-5473-e053-2995a90ad0d52025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
Coppertone Kids Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc068a6e7-260f-0766-e053-2995a90a422f2025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
unii: 4Y5P7MUD51
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
unii: 4Y5P7MUD51
Sei Bella CC Brightening Creme FairOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6892952a-d032-30bf-e053-2a91aa0a3bba2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
unii: 4Y5P7MUD51
Sei Bella CC Brightening Creme Medium TanOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4e8b4-36cb-6306-e053-2a91aa0a6d252025-12-31WarningsExact identifier
unii: 15FIX9V2JP
unii: 4Y5P7MUD51
Sei Bella CC Brightening Creme MediumOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4ed34-f492-67a6-e053-2a91aa0a04282025-12-31WarningsExact identifier
unii: 15FIX9V2JP
unii: 4Y5P7MUD51
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 SunscreenSUNSCREENMelaleuca Inc.1f1d1575-cf37-5d66-e063-6394a90ab2a32025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e5326-73c3-9fa8-e053-2a95a90aae9d2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e3f45-8e6f-6a3f-e053-2995a90a17d22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Deep 550 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e31a82-0cd0-5a1a-e053-2991aa0a33f82025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2dfaa-d173-e6a9-e053-2a91aa0a46632025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 300 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c583-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30231-4fba-35d4-e053-2991aa0a33cb2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 440 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-5640-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-564f-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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