FDA.reportPublic FDA data

KLENSKIN SHOWERON SUNSCREEN SPA

Product NDC
61369-103
11-digit product format
613690103
Labeler code
61369
Product ID
61369-103_d8286f7c-e21e-13a2-e053-2995a90aa82a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTOCRYLENE, OCTINOXATE
Dosage form
GEL
Route
TOPICAL
Labeler
CoLabs Intl. Corp
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-28
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
3 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61369-103IInactivated by FDA2026-10-15
excluded packagepackage61369-10361369-103-18IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-103-18KLENSKIN SHOWERON SUNSCREEN SPASPF-30236 mL in 1 BOTTLEGEL2366

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
CAMELLIA OLEIFERA SEEDINACTIVE INGREDIENT59ED29FM2JKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
CRANBERRY SEED OILINACTIVE INGREDIENT73KDS3BW5EKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
DIISOSTEARYL DIMER DILINOLEATEINACTIVE INGREDIENT04P17590APKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
ETHYLENEDIAMINEINACTIVE INGREDIENT60V9STC53FKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
GELLAN GUM (LOW ACYL)INACTIVE INGREDIENT7593U09I4DKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGGKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WTKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
HYDROXYETHYL LAURDIMONIUM CHLORIDEINACTIVE INGREDIENT8467K53E3YKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
LAURYL GLUCOSIDEINACTIVE INGREDIENT76LN7P7UCUKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
POLYQUATERNIUM-10 (125 MPA.S AT 2%)INACTIVE INGREDIENTL45WU8S981KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
POMEGRANATE SEED OILINACTIVE INGREDIENT0UI45XV0T6KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
RASPBERRY SEED OILINACTIVE INGREDIENT9S8867952AKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SHEANUT OILINACTIVE INGREDIENTO88E196QRFKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SODIUM LAURYL GLYCOL CARBOXYLATEINACTIVE INGREDIENT8L0472VMYLKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RKLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-103KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]6Legacy NDC, 1 package rows20240116_e0bca93b-01ad-45d5-860a-d2a34d085dd9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61369-103-1861369010318236 mL in 1 BOTTLE (61369-103-18) 236 ml2014-07-280000-00-00NoNoCurrent