NDC 13537-031-01 - LBEL Hydra Calme 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
13537-031
Requested NDC
13537-031-01
Package NDCs from labels
13537-031-01, 13537-031-02, 13537-031-03, 13537-031-04, 13537-031-05
Manufacturer
Ventura Corporation Ltd. (San Juan, P.R) | Bel Star, S.A. | Yobel Supply Chain Management S.A.
Effective date
2011-09-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
L'BEL HYDRA CALMEVentura Corporation Ltd. (San Juan, P.R) | Bel Star, S.A. | Yobel Supply Chain Management S.A.2011-09-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
13537-031-022025-02-20L'BEL HYDRA CALME
13537-031-042025-02-20L'BEL HYDRA CALME
13537-031-052025-02-20L'BEL HYDRA CALME
13537-031-022019-10-29L'BEL HYDRA CALME
13537-031-042019-10-29L'BEL HYDRA CALME
13537-031-052019-10-29L'BEL HYDRA CALME

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OctisalateACTIVE INGREDIENT4X49Y0596WLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OctinoxateACTIVE MOIETY4Y5P7MUD51LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OctisalateACTIVE MOIETY4X49Y0596WLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RALBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
c12-20 alkyl glucosideINACTIVE INGREDIENTK67N5Z1RUALBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
c14-22 alcoholsINACTIVE INGREDIENTB1K89384RJLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
c20-22 alcoholsINACTIVE INGREDIENTO4M0347C6ALBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
c20-22 alkyl phosphateINACTIVE INGREDIENTL4VKP0Y7RPLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cetearyl glucosideINACTIVE INGREDIENT09FUA47KNALBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
chlorella vulgarisINACTIVE INGREDIENTRYQ4R60M02LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cyclomethicone 6INACTIVE INGREDIENTXHK3U310BALBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
erythritolINACTIVE INGREDIENTRA96B954X6LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
ethylparabenINACTIVE INGREDIENT14255EXE39LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
isobutylparabenINACTIVE INGREDIENT0QQJ25X58GLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
isohexadecaneINACTIVE INGREDIENT918X1OUF1ELBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
peaINACTIVE INGREDIENTW4X7H8GYFMLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
rubus chamaemorus fruitINACTIVE INGREDIENT74CW8G72Q6LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
sorbic acidINACTIVE INGREDIENTX045WJ989BLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
trolamineINACTIVE INGREDIENT9O3K93S3TKLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
waterINACTIVE INGREDIENT059QF0KO0RLBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEELBEL (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [VENTURA CORPORATION LTD. (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 9 of 277 · 5,524 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
unii: 4X49Y0596W
Eucerin Radiant Tone Tinted Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc596a4204-3d29-9023-e063-6294a90ad99e2026-08-10WarningsExact identifier
unii: 4X49Y0596W
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
unii: 4X49Y0596W
unii: 4Y5P7MUD51
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
unii: 4X49Y0596W
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 4Y5P7MUD51
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
NHLMA Skin Defense SunscreenBROAD SPECTRUM SPF 30NATIONAL HAIR LOSS LLC56326ae0-387f-ad08-e063-6294a90acc4f2026-08-06WarningsExact identifier
unii: 4X49Y0596W
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
unii: 92RU3N3Y1O
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
unii: 4X49Y0596W
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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