LBEL UV DEFENSE 365

Product NDC
13537-402
11-digit product format
135370402
Labeler code
13537
Product ID
13537-402_38b1a1b0-a33d-404c-8214-b9cbf57a478c
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Ventura Corporation Ltd. (San Juan, P.R)
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-08-29
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-402-022019-10-29C16284748780-1960f7f55-cff5-8e05-e053-dbdaa90a074aL'BEL UV DÉFENSE 365
13537-402-042019-10-29C16284748780-1960f7f55-cff5-8e05-e053-dbdaa90a074aL'BEL UV DÉFENSE 365
13537-402-052019-10-29C16284748780-1960f7f55-cff5-8e05-e053-dbdaa90a074aL'BEL UV DÉFENSE 365

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13537-402-01LBEL UV DEFENSE 36530 mL in 1 BOTTLELOTION301
13537-402-02LBEL UV DEFENSE 3651 in 1 BOXLOTION11
13537-402-03LBEL UV DEFENSE 3653 mL in 1 BOTTLELOTION31
13537-402-04LBEL UV DEFENSE 3651 in 1 BOXLOTION11
13537-402-05LBEL UV DEFENSE 3651 mL in 1 PACKETLOTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95SLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OctisalateACTIVE INGREDIENT4X49Y0596WLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
HomosalateACTIVE MOIETYV06SV4M95SLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OctinoxateACTIVE MOIETY4Y5P7MUD51LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OctisalateACTIVE MOIETY4X49Y0596WLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
ambrosia peruviana leafINACTIVE INGREDIENT458F79CGBFLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RALBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
caprylyl glycolINACTIVE INGREDIENT00YIU5438ULBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
ceteareth-12INACTIVE INGREDIENT7V4MR24V5PLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
cyclomethicone 6INACTIVE INGREDIENTXHK3U310BALBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
dicaprylyl carbonateINACTIVE INGREDIENT609A3V1SUALBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
hedera helix topINACTIVE INGREDIENT379040L9FWLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
micaINACTIVE INGREDIENTV8A1AW0880LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
phytic acidINACTIVE INGREDIENT7IGF0S7R8ILBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UTLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
propylheptyl caprylateINACTIVE INGREDIENT991Z19V2ODLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
sunflower seedINACTIVE INGREDIENTR9N3379M4ZLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
triethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08ELBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
waterINACTIVE INGREDIENT059QF0KO0RLBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEELBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13537-402LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)]1Legacy NDC, 5 package rows20110902_0873d6a1-55df-415e-8f95-2d08ef7ee84f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
13537-402-011353704020130 mL in 1 BOTTLE30 mlHistorical
13537-402-02135370402021 in 1 BOXHistorical
13537-402-03135370402033 mL in 1 BOTTLE3 mlHistorical
13537-402-04135370402041 in 1 BOXHistorical
13537-402-05135370402051 mL in 1 PACKET1 mlHistorical