FDA.reportPublic FDA data

KLENSKIN KIDS SHOWERON SUNSCREEN

Product NDC
61369-102
Requested package NDC
61369-102-18
11-digit product format
613690102
Labeler code
61369
Product ID
61369-102_d8288be1-ec61-1096-e053-2995a90a4c5f
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61369-10261369-102-18IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-102-18KLENSKIN KIDS SHOWERON SUNSCREENSPF-30236 mL in 1 BOTTLEGEL23610

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
AVOBENZONEACTIVE MOIETYG63QQF2NOXKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
OCTINOXATEACTIVE MOIETY4Y5P7MUD51KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
CRANBERRY SEED OILINACTIVE INGREDIENT73KDS3BW5EKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
DIISOSTEARYL DIMER DILINOLEATEINACTIVE INGREDIENT04P17590APKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
ETHYLENEDIAMINEINACTIVE INGREDIENT60V9STC53FKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
GELLAN GUM (LOW ACYL)INACTIVE INGREDIENT7593U09I4DKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WTKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
LAURYL GLUCOSIDEINACTIVE INGREDIENT76LN7P7UCUKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
LAURYL SULFOSUCCINATEINACTIVE INGREDIENTL81TQ3126PKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AMKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESINACTIVE INGREDIENTGO50W2HWO8KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)INACTIVE INGREDIENTGMR4PEN8PKKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
POMEGRANATEINACTIVE INGREDIENT56687D1Z4DKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
RASPBERRY SEED OILINACTIVE INGREDIENT9S8867952AKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SHEANUT OILINACTIVE INGREDIENTO88E196QRFKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SODIUM LAURYL GLYCOL CARBOXYLATEINACTIVE INGREDIENT8L0472VMYLKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5
WATERINACTIVE INGREDIENT059QF0KO0RKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-102KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]10Legacy NDC, 1 package rows20240116_2e394662-dd0a-4d0d-b4b0-568ecf7e2555.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61369-102-1861369010218236 mL in 1 BOTTLE (61369-102-18) 236 ml2014-07-280000-00-00NoNoCurrent