KLENSKIN KIDS SHOWERON SUNSCREEN

Product NDC: 61369-102
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61369-102		I	Inactivated by FDA		2026-10-15
excluded package	package	61369-102	61369-102-18	I	Inactivated by FDA		2026-10-15

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 concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61369-102-18	KLENSKIN KIDS SHOWERON SUNSCREENSPF-30	236 mL in 1 BOTTLE	GEL	236		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
CRANBERRY SEED OIL	INACTIVE INGREDIENT	73KDS3BW5E	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
DIISOSTEARYL DIMER DILINOLEATE	INACTIVE INGREDIENT	04P17590AP	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
ETHYLENEDIAMINE	INACTIVE INGREDIENT	60V9STC53F	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
GELLAN GUM (LOW ACYL)	INACTIVE INGREDIENT	7593U09I4D	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)	INACTIVE INGREDIENT	ZR28QKN0WT	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
LAURYL GLUCOSIDE	INACTIVE INGREDIENT	76LN7P7UCU	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
LAURYL SULFOSUCCINATE	INACTIVE INGREDIENT	L81TQ3126P	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
PEG-150 PENTAERYTHRITYL TETRASTEARATE	INACTIVE INGREDIENT	8L4OOQ76AM	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES	INACTIVE INGREDIENT	GO50W2HWO8	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)	INACTIVE INGREDIENT	GMR4PEN8PK	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
POMEGRANATE	INACTIVE INGREDIENT	56687D1Z4D	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
RASPBERRY SEED OIL	INACTIVE INGREDIENT	9S8867952A	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SHEANUT OIL	INACTIVE INGREDIENT	O88E196QRF	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SODIUM COCOYL ISETHIONATE	INACTIVE INGREDIENT	518XTE8493	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SODIUM LAURYL GLYCOL CARBOXYLATE	INACTIVE INGREDIENT	8L0472VMYL	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SODIUM METHYL COCOYL TAURATE	INACTIVE INGREDIENT	JVL98CG53G	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61369-102	KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	10	Legacy NDC, 1 package rows	20240116_2e394662-dd0a-4d0d-b4b0-568ecf7e2555.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61369-102-18	61369010218	236 mL in 1 BOTTLE (61369-102-18)	236 ml	2014-07-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COLABS - KLENSKIN KIDS SHOWERON SUNSCREEN SPF 30(61369-102)	CoLabs Intl. Corp	2024-01-15	HUMAN OTC DRUG LABEL	10