KLENSKIN SHOWERON SUNSCREEN

Product NDC: 61369-101
Requested package NDC: 61369-101-18
11-digit product format: 613690101
Labeler code: 61369
Product ID: 61369-101_d8288a2c-dc92-cc66-e053-2a95a90a7c4e
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61369-101	61369-101-18	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61369-101-18	2024-01-30	C162847	48780-1	1030e364-fe3e-111a-e063-dadaa90a10e2	COLABS - Klenskin Wash On Shampoo, Face & Body Wash SPF 30, Fragrance Free (61369-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61369-101-18	KLENSKIN 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 SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
CAMELLIA OLEIFERA SEED	INACTIVE INGREDIENT	59ED29FM2J	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
CRANBERRY SEED OIL	INACTIVE INGREDIENT	73KDS3BW5E	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
DIISOSTEARYL DIMER DILINOLEATE	INACTIVE INGREDIENT	04P17590AP	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
DISTEARYLDIMONIUM CHLORIDE	INACTIVE INGREDIENT	OM9573ZX3X	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
ETHYLENEDIAMINE	INACTIVE INGREDIENT	60V9STC53F	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
GELLAN GUM (LOW ACYL)	INACTIVE INGREDIENT	7593U09I4D	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
GRAPE SEED OIL	INACTIVE INGREDIENT	930MLC8XGG	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)	INACTIVE INGREDIENT	ZR28QKN0WT	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
HYDROXYETHYL LAURDIMONIUM CHLORIDE	INACTIVE INGREDIENT	8467K53E3Y	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
LAURYL GLUCOSIDE	INACTIVE INGREDIENT	76LN7P7UCU	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
POLYQUATERNIUM-10 (125 MPA.S AT 2%)	INACTIVE INGREDIENT	L45WU8S981	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
POMEGRANATE SEED OIL	INACTIVE INGREDIENT	0UI45XV0T6	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
RASPBERRY SEED OIL	INACTIVE INGREDIENT	9S8867952A	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SHEANUT OIL	INACTIVE INGREDIENT	O88E196QRF	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SODIUM LAURYL GLYCOL CARBOXYLATE	INACTIVE INGREDIENT	8L0472VMYL	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61369-101	KLENSKIN SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]	10	Legacy NDC, 1 package rows	20220217_00d73e47-97fd-4fe7-80d4-bf19ed0c9dda.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
61369-101-18	61369010118	236 mL in 1 BOTTLE (61369-101-18)	236 ml	2014-07-28	0000-00-00	No	No	Current