FDA.reportPublic FDA data

Algenist

Product NDC
53407-155
11-digit product format
534070155
Labeler code
53407
Product ID
53407-155_ce6c13f4-9b9f-415f-9a3f-0b8b8cad7c50
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Solazyme, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-08-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30 mg/mL; mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53407-155-602019-12-02C16284748780-19855d018-dc34-cd31-e053-dbdaa90ab51a64952f6a-eea3-4217-bdd1-8b492b945aba
53407-155-602019-11-27C16284748780-19855d018-dc34-cd31-e053-dbdaa90ab51a64952f6a-eea3-4217-bdd1-8b492b945aba

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
HomosalateACTIVE INGREDIENTV06SV4M95SALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
OctisalateACTIVE INGREDIENT4X49Y0596WALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
AvobenzoneACTIVE MOIETYG63QQF2NOXALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
HomosalateACTIVE MOIETYV06SV4M95SALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
OctisalateACTIVE MOIETY4X49Y0596WALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
ALARIA ESCULENTAINACTIVE INGREDIENTEJ9JK8J58DALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
ANNICKIA CHLORANTHA BARKINACTIVE INGREDIENTH70115MP4AALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
APPLEINACTIVE INGREDIENTB423VGH5S9ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
BiotinINACTIVE INGREDIENT6SO6U10H04ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
caprylyl glycolINACTIVE INGREDIENT00YIU5438UALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
Cetyl PhosphateINACTIVE INGREDIENTVT07D6X67OALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
DI-C12-15 ALKYL FUMARATEINACTIVE INGREDIENTA1CB3Z898PALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
ERGOTHIONEINEINACTIVE INGREDIENTBDZ3DQM98WALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
ethylhexylglycerinINACTIVE INGREDIENT147D247K3PALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
mannitolINACTIVE INGREDIENT3OWL53L36AALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
Peg-100 StearateINACTIVE INGREDIENTYD01N1999RALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
Pentylene GlycolINACTIVE INGREDIENT50C1307PZGALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
Tetrapeptide-21INACTIVE INGREDIENT179JUC43HUALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEALGENIST (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SOLAZYME, INC.]3