CoreTex Sun X SPF 30 Thin

Product NDC: 65753-101
Requested package NDC: 65753-101-22
11-digit product format: 657530101
Labeler code: 65753
Product ID: 65753-101_0847f22b-ece4-e4c1-e063-6394a90a4d62
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone
Dosage form: LIQUID
Route: TOPICAL
Labeler: CoreTex Products Inc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-11-22
Substance: AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 1; 5; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	65753-101	65753-101-22	D	Discontinued by firm		2026-10-27

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 · 12 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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CoreTex Sun X SPF 30 Thin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	1 g/100mL
HOMOSALATE	5 g/100mL
OCTINOXATE	7.5 g/100mL
OCTISALATE	5 g/100mL
OXYBENZONE	6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
980388b5-8314-3143-e053-2995a90a7288	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65753-101-11	CoreTex Sun X SPF 30 Thin	59 mL in 1 BOTTLE, SPRAY	LIQUID	59		6
65753-101-12	CoreTex Sun X SPF 30 Thin	118 mL in 1 BOTTLE, SPRAY	LIQUID	118		6
65753-101-22	CoreTex Sun X SPF 30 Thin	7 mL in 1 PACKET	LIQUID	7		6
65753-101-22	CoreTex Sun X SPF 30 Thin	25 in 1 CONTAINER	LIQUID	25		6
65753-101-23	CoreTex Sun X SPF 30 Thin	50 in 1 CONTAINER	LIQUID	50		6
65753-101-23	CoreTex Sun X SPF 30 Thin	7 mL in 1 PACKET	LIQUID	7		6
65753-101-24	CoreTex Sun X SPF 30 Thin	50 in 1 CARTON	LIQUID	50		6
65753-101-24	CoreTex Sun X SPF 30 Thin	7 mL in 1 PACKET	LIQUID	7		6
65753-101-25	CoreTex Sun X SPF 30 Thin	100 in 1 CARTON	LIQUID	100		6
65753-101-25	CoreTex Sun X SPF 30 Thin	7 mL in 1 PACKET	LIQUID	7		6
65753-101-26	CoreTex Sun X SPF 30 Thin	300 in 1 BOX	LIQUID	300		6
65753-101-26	CoreTex Sun X SPF 30 Thin	7 mL in 1 PACKET	LIQUID	7		6
65753-101-27	CoreTex Sun X SPF 30 Thin	7 mL in 1 PACKET	LIQUID	7		6
65753-101-27	CoreTex Sun X SPF 30 Thin	16 in 1 BOX	LIQUID	16		6
65753-101-10	SunX SPF 30/BugX Wallmount	7 mL in 1 POUCH	LIQUID	350 mL	7.5 g in 100mL	1
65753-101-10	SunX SPF 30/BugX Wallmount	7 mL in 1 POUCH	LIQUID	350 mL	7.5 g in 100mL	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65753-101	CORETEX SUN X SPF 30 THIN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LIQUID [CORETEX PRODUCTS INC]	6	Current NDC, Legacy NDC, 14 package rows	20231022_980388b5-8314-3143-e053-2995a90a7288.zip
65753-101	SUNX SPF 30/BUGX WALLMOUNT KIT [CORETEX PRODUCTS INC]	1	Current NDC, Legacy NDC	20231022_0846946b-a05d-826c-e063-6294a90a0a0f.zip
65753-101	SUNX SPF 30/BUGX WALLMOUNT KIT [CORETEX PRODUCTS INC]	1	Current NDC, Legacy NDC	20231022_08480b2a-a888-fb00-e063-6294a90a41ea.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 96 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coppertone Tanning Sunscreen SPF 15	AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	cc5dafd4-dfd4-d310-e053-2995a90a82a8	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone EveryTone Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	04c58384-fd82-f6d0-e063-6294a90a3ff1	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdort Inc	cc46b3a3-48f5-4593-e053-2995a90a8782	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sport SPF 60 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23fb7304-789d-1f94-e063-6394a90a7e62	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	cbf9a785-f218-76fb-e053-2995a90a8e03	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	b60c2a38-ef92-0dff-e053-2995a90a47c4	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	0a5a5370-ec6f-42a7-e063-6394a90ac37c	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d53e1253-f6a4-4f3d-e053-2a95a90a79ed	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Face SPF 60 Plus Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	04b36eb1-bffc-c31e-e063-6294a90a8eb3	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d47460a1-4768-ee44-e053-2a95a90adecf	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sunscreen SPF 50	ZINC OXIDE 20%	Beiersdorf Inc	d46359e7-b585-c43a-e053-2995a90a0863	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d473e7ed-4a9f-76fe-e053-2995a90ab37d	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	f3e3f4c6-2cb9-7b17-e053-2a95a90a3854	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23f88c88-b68e-4706-e063-6294a90afb38	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	d473113d-2fc3-6b1c-e053-2a95a90a88ed	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%	Beiersdorf Inc	d89df7a5-7741-3e1d-e053-2995a90ae275	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d475e14f-dab1-dec5-e053-2995a90aef73	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d4757d99-bac6-48fb-e053-2a95a90ab1bf	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	24d3fbbc-0bce-b47a-e063-6394a90a9afa	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Light	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6894b9d9-a5b5-4c98-e053-2991aa0a9ca2	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65753-101-22	65753010122	25 PACKET in 1 CONTAINER (65753-101-22) > 7 mL in 1 PACKET	25 packet	2019-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sun X SPF 30 Thin 65753-101	CoreTex Products Inc \| Pure Source	2023-10-22	HUMAN OTC DRUG LABEL	6
SunX SPF 30/BugX Wallmount 65753-511	CoreTex Products Inc \| Pure Source	2023-10-22	HUMAN OTC DRUG LABEL	1
SunX SPF 30/BugX Wallmount 65753-510	CoreTex Products Inc \| Pure Source	2023-10-11	HUMAN OTC DRUG LABEL	1
SunX SPF 30/BugX Wallmount	CoreTex Products Inc \| Pure Source	2022-11-21	HUMAN OTC DRUG LABEL	4
SunX SPF 30/BugX Free Wallmount	CoreTex Products Inc \| Pure Source	2022-11-21	HUMAN OTC DRUG LABEL	3