FDA.reportPublic FDA data

STOP THE CLOCK BROAD SPECTRUM SPF 50

Product NDC
42485-006
11-digit product format
424850006
Labeler code
42485
Product ID
42485-006_3aca1373-e465-44ff-8379-0366d682e837
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, titanium dioxide, zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Biopelle, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-08-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42485-006-012019-11-13C16284748780-197449f38-c857-f6ea-e053-dbdaa90aa703Stop the Clock Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42485-006-01STOP THE CLOCK BROAD SPECTRUM SPF 5050 mL in 1 JARCREAM501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
.GAMMA.-AMINOBUTYRIC ACIDINACTIVE INGREDIENT2ACZ6IPC6ISTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
ADENOSINE TRIPHOSPHATEINACTIVE INGREDIENT8L70Q75FXESTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
C18-36 ACID TRIGLYCERIDEINACTIVE INGREDIENTZRA72DR3R7STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438USTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
CAT'S CLAWINACTIVE INGREDIENT9060PRM18QSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
DIMETHICONOL (41 MPA.S)INACTIVE INGREDIENT343C7U75XWSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
DIPALMITOYL HYDROXYPROLINEINACTIVE INGREDIENTE6AHA53N1HSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
EUGENOLINACTIVE INGREDIENT3T8H1794QWSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
HEXANOYL DIPEPTIDE-3 NORLEUCINE ACETATEINACTIVE INGREDIENTP8A02Z93M6STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
N-ACETYL-TYROSINEINACTIVE INGREDIENTDA8G610ZO5STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
POLYISOBUTYLENE (1000 MW)INACTIVE INGREDIENT5XB3A63Y52STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
POLYSILICONE-15INACTIVE INGREDIENTF8DRP5BB29STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
PORPHYRA UMBILICALISINACTIVE INGREDIENT14AN0J70WOSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
POTATOINACTIVE INGREDIENTCFE1S8DYWDSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
SODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT65A9F4P024STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ESTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESTOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42485-006STOP THE CLOCK BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]1Legacy NDC, 1 package rows20111014_1725b5af-fe03-4372-beaf-d6fd9088a1f1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42485-006-014248500060150 mL in 1 JAR50 mlHistorical