CoreTex Sun X SPF 30

Product NDC: 65753-100
Requested package NDC: 65753-100-37
11-digit product format: 657530100
Labeler code: 65753
Product ID: 65753-100_cddeec78-6f38-34aa-e053-2995a90a4098
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: CoreTex Products
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-01-25
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	65753-100	65753-100-37	D	Discontinued by firm		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 · 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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
COMFREY LEAF	INACTIVE INGREDIENT	DG4F8T839X	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
DIMETHYL CAPRAMIDE	INACTIVE INGREDIENT	O29Y6X2JEZ	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
NASTURTIUM OFFICINALE	INACTIVE INGREDIENT	YH89GMV676	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]	1

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
65753-100-37	65753010037	44 mL in 1 PACKET (65753-100-37)	44 ml	2013-01-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CoreTex Professional Outdoor Skin Protection Wallet and Refill Wallet	CoreTex Products Inc \| Cosmetic Enterprises \| Pure Source \| Raining Rose \| HealthSpecialty	2022-11-21	HUMAN OTC DRUG LABEL	2
4362 First Aid Kit	Honeywell Safety Products USA, Inc.	2021-12-23	HUMAN OTC DRUG LABEL	3
Sun X SPF 30 Thick	CoreTex Products \| Pure Source	2021-10-08	HUMAN OTC DRUG LABEL	8

CoreTex Sun X SPF 30

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#