LBEL UV DEFENSE 365

Product NDC
14783-094
11-digit product format
147830094
Labeler code
14783
Product ID
14783-094_56625705-f317-4a80-9167-edcfacaf5d93
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
Ventura International 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
14783-094-022019-10-29C16284748780-1960f7f55-cbf3-8e05-e053-dbdaa90a074aL'BEL UV DÉFENSE 365
14783-094-042019-10-29C16284748780-1960f7f55-cbf3-8e05-e053-dbdaa90a074aL'BEL UV DÉFENSE 365
14783-094-052019-10-29C16284748780-1960f7f55-cbf3-8e05-e053-dbdaa90a074aL'BEL UV DÉFENSE 365

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14783-094-01LBEL UV DEFENSE 36530 mL in 1 BOTTLELOTION/SHAMPOO301
14783-094-02LBEL UV DEFENSE 3651 in 1 BOXLOTION/SHAMPOO11
14783-094-03LBEL UV DEFENSE 3653 mL in 1 BOTTLELOTION/SHAMPOO31
14783-094-04LBEL UV DEFENSE 3651 in 1 BOXLOTION/SHAMPOO11
14783-094-05LBEL UV DEFENSE 3651 mL in 1 PACKETLOTION/SHAMPOO11

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14783-094LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION/SHAMPOO [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]1Legacy NDC, 5 package rows20110902_1655bbef-303a-4719-9d28-22a3c7d641f6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
14783-094-011478300940130 mL in 1 BOTTLE30 mlHistorical
14783-094-02147830094021 in 1 BOXHistorical
14783-094-03147830094033 mL in 1 BOTTLE3 mlHistorical
14783-094-04147830094041 in 1 BOXHistorical
14783-094-05147830094051 mL in 1 PACKET1 mlHistorical