Destination Brands International

Product NDC
58443-0190
11-digit product format
584430190
Labeler code
58443
Product ID
58443-0190_9c5964a8-114d-17be-e053-2a95a90a68ce
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene and oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-13
Marketing end
0000-00-00
Substance
OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0190-32023-01-30C16284748780-1f386c64a-2d80-0266-e053-dadaa90a7c1aMiami Beach Kids SPF 50 Broad Spectrum Lotion Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0190-3Destination Brands InternationalBROAD SPECTRUM SPF 50 Sunscreen89 mL in 1 BOTTLELOTION893

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
(C10-C30)ALKYL METHACRYLATE ESTERINACTIVE INGREDIENTXH2FQZ38D8DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06ADESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
BETA CAROTENEINACTIVE INGREDIENT01YAE03M7JDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
CRAMBE MARITIMA LEAFINACTIVE INGREDIENTNO0DI2V62BDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
ISOPROPYLPHTHALIMIDEINACTIVE INGREDIENT1J1MM83329DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
N-BUTYLPHTHALIMIDEINACTIVE INGREDIENT5TH1DKT35EDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
PSEUDOPTEROGORGIA ELISABETHAEINACTIVE INGREDIENTUDY3H1OUX5DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
TOMATOINACTIVE INGREDIENTZ4KHF2C175DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
TRICAPRININACTIVE INGREDIENTO1PB8EU98MDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0190DESTINATION BRANDS INTERNATIONAL BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]3Legacy NDC, 1 package rows20200118_20d2e1fd-5882-0477-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0190-35844301900389 mL in 1 BOTTLE (58443-0190-3) 89 ml2015-01-130000-00-00NoNoCurrent