CoreTex Sun X SPF 30

Product NDC
65753-100
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 · 21 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65753-100DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-01DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-02DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-03DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-04DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-05DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-07DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-08DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-09DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-10DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-18DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-22DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-32DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-33DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-34DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-37DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-40DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-41DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-42DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-43DDiscontinued by firm2026-10-05
excluded packagepackage65753-10065753-100-44DDiscontinued by firm2026-10-05

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 5 · 252 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-37d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-41d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-44d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-34d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-22d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-33d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-43d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-100-42d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-37f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-41f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-44f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-34f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-22f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-33f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-43f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-100-42f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-372ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-412ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-442ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-342ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-222ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-332ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-100-012ef7874e63bc…57b86245f4fa…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
HOMOSALATEACTIVE MOIETYV06SV4M95SCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
OCTISALATEACTIVE MOIETY4X49Y0596WCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ECORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
DIMETHYL CAPRAMIDEINACTIVE INGREDIENTO29Y6X2JEZCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
NASTURTIUM OFFICINALEINACTIVE INGREDIENTYH89GMV676CORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0RCORETEX SUN X SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [CORETEX PRODUCTS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65753-100-016575301000130 mL in 1 BOTTLE, PLASTIC (65753-100-01) 30 ml2019-11-260000-00-00NoNoCurrent
65753-100-026575301000259 mL in 1 BOTTLE, PLASTIC (65753-100-02) 59 ml2013-01-250000-00-00NoNoCurrent
65753-100-0365753010003118 mL in 1 BOTTLE, PLASTIC (65753-100-03) 118 ml2013-01-250000-00-00NoNoCurrent
65753-100-0465753010004177 mL in 1 BOTTLE, PLASTIC (65753-100-04) 177 ml2013-01-250000-00-00NoNoCurrent
65753-100-0565753010005236 mL in 1 BOTTLE, PLASTIC (65753-100-05) 236 ml2013-01-250000-00-00NoNoCurrent
65753-100-0765753010007473 mL in 1 BOTTLE, PLASTIC (65753-100-07) 473 ml2013-01-250000-00-00NoNoCurrent
65753-100-08657530100081 BAG in 1 BOX (65753-100-08) > 500 mL in 1 BAG1 bag2013-01-250000-00-00NoNoCurrent
65753-100-0965753010009946 mL in 1 BOTTLE, PLASTIC (65753-100-09) 946 ml2013-01-250000-00-00NoNoCurrent
65753-100-10657530100103785 mL in 1 BOTTLE, PLASTIC (65753-100-10) 3785 ml2013-01-250000-00-00NoNoCurrent
65753-100-18657530100181000 PACKET in 1 CARTON (65753-100-18) > 44 mL in 1 PACKET1000 packet2013-01-250000-00-00NoNoCurrent
65753-100-226575301002225 PACKET in 1 CONTAINER (65753-100-22) > 7 mL in 1 PACKET25 packet2013-01-250000-00-00NoNoCurrent
65753-100-326575301003244 mL in 1 BOTTLE, PLASTIC (65753-100-32) 44 ml2013-01-250000-00-00NoNoCurrent
65753-100-336575301003359 mL in 1 BOTTLE, PLASTIC (65753-100-33) 59 ml2013-01-250000-00-00NoNoCurrent
65753-100-3465753010034118 mL in 1 BOTTLE, PLASTIC (65753-100-34) 118 ml2013-01-250000-00-00NoNoCurrent
65753-100-376575301003744 mL in 1 PACKET (65753-100-37) 44 ml2013-01-250000-00-00NoNoCurrent
65753-100-40657530100401 BOTTLE in 1 BOX (65753-100-40) > 751 mL in 1 BOTTLE (65753-100-35) 1 bottle2017-01-010000-00-00NoNoCurrent
65753-100-416575301004150 PACKET in 1 CONTAINER (65753-100-41) > 7 mL in 1 PACKET50 packet2013-01-250000-00-00NoNoCurrent
65753-100-426575301004250 PACKET in 1 CARTON (65753-100-42) > 7 mL in 1 PACKET50 packet2013-01-250000-00-00NoNoCurrent
65753-100-4365753010043100 PACKET in 1 CARTON (65753-100-43) > 7 mL in 1 PACKET100 packet2013-01-250000-00-00NoNoCurrent
65753-100-4465753010044300 PACKET in 1 BOX (65753-100-44) > 7 mL in 1 PACKET300 packet2013-01-250000-00-00NoNoCurrent