Lifecell

Product NDC
58443-0194
Requested package NDC
58443-0194-3
11-digit product format
584430194
Labeler code
58443
Product ID
58443-0194_9c59cd3a-9b28-731b-e053-2995a90aa963
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-05
Marketing end
0000-00-00
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OXYBENZONE
Active strength
28 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

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0LIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3LIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
CARBOMER INTERPOLYMER TYPE A (55000 CPS)INACTIVE INGREDIENT59TL3WG5COLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7LIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
ISOPROPYLPHTHALIMIDEINACTIVE INGREDIENT1J1MM83329LIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFALIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
N-BUTYLPHTHALIMIDEINACTIVE INGREDIENT5TH1DKT35ELIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)INACTIVE INGREDIENT5Z4DPO246ALIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M46LIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIFECELL BROAD SPECTRUM SPF 50 BB SHEER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [PRIME ENTERPRISES INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0194-35844301940350 mL in 1 TUBE (58443-0194-3) 50 ml2015-10-050000-00-00NoNoCurrent