Home NDC 65753-101 CoreTex Sun X SPF 30 Thin
Product NDC 65753-101
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
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 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 342 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE Autumn Harp fd6807e1-c8c0-b361-e053-6294a90aea0c 2023-06-05 Warnings Exact identifier application number: M020 Thinksport Clear Zinc SPF 50 ZINC OXIDE thinkOperations,LLC b5ce523f-eee8-f1a8-da19-b3dc14f8a58e 2023-05-31 Warnings Exact identifier application number: M020 Thinksport Mineral SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE thinkOperations,LLC 77b63c0b-353b-4f5f-95c7-6f7eeab81471 2023-05-30 Warnings Exact identifier application number: M020 Think Kids Mineral SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE thinkOperations,LLC 25c59820-a08d-4abe-87ae-a787ac8b2ac2 2023-05-30 Warnings Exact identifier application number: M020 Topix Mineral Mattifying Tinted Sunscreeninted SPF 50 ZINC OXIDE Topiderm, Inc. 46c6f20f-4bb6-47c6-9eac-17ca97bb14a7 2023-03-20 Warnings Exact identifier application number: M020 Replenix Sunscreen SPF 50 ZINC OXIDE Topiderm, Inc. 9223ffa8-7af3-4407-9170-482afec536d8 2023-02-24 Warnings Exact identifier application number: M020 Bath and Body Works SPF20 Coconut Lip Balm SPF20 LIP BALM Autumn Harp f5744a48-2b39-4949-e053-2a95a90ab15d 2023-02-24 Warnings Exact identifier application number: M020 Replenix Tinted Sunscreen SPF 50 ZINC OXIDE AND OCTINOXATE Topiderm, Inc. 1fda4a54-e323-4f3c-b659-bded4b1b3dd0 2023-02-22 Warnings Exact identifier application number: M020 Topix Mineral Mattifying Tinted Sunscreen SPF 50 ZINC OXIDE Topiderm, Inc. ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e91 2023-02-22 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 3a637542-0f79-47ae-815d-84d0036c737a 2023-02-13 Warnings Exact identifier application number: M020 Essential Moisturizing Sunscreen ZINC OXIDE, OCTINOXATE Topiderm, Inc. 450d916e-4c77-489e-86b1-78b686355476 2023-02-09 Warnings Exact identifier application number: M020 Mineral Repair SPF 45 ZINC OXIDE Topiderm, Inc. 84580f10-3119-4253-87a6-53d24a1f2227 2023-02-07 Warnings Exact identifier application number: M020 Think Aloe and Tea Leaves Zinc oxide ZINC OXIDE thinkOperations,LLC 9965ccd1-821d-4d9d-8a56-e87440b809ee 2023-02-02 Warnings Exact identifier application number: M020 Replenix Lip Therapy homosalate HOMOSALATE Topiderm, Inc. b60dc004-d713-47bc-a6e9-ea4783aa7019 2023-02-02 Warnings Exact identifier application number: M020 Josie Maran Argan Daily Moisturizer SPF47 ZINC OXIDE, TITANIUM DIOXIDE Autumn Harp, Inc. 027821e6-db7d-4c03-956a-00313488ebc7 2023-01-14 Boxed warning, Warnings Exact identifier application number: M020 Tinted Lip Balm SPF30 Wild Peony SPF30 LIP BALM Autumn Harp d0604720-623a-e8a9-e053-2995a90ab0e6 2023-01-10 Warnings Exact identifier application number: M020 Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a39d91c-2dcf-71d6-e063-6394a90a5474 2022-02-10 Warnings Exact identifier application number: M020 Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3a63d3-c7e0-bf03-e063-6394a90a1662 2022-02-10 Warnings Exact identifier application number: M020 Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3c0aa0-7501-7ef0-e063-6294a90a9f94 2022-02-10 Warnings Exact identifier application number: M020 Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35 OCTINOXATE AND OXYBENZONE Groupe Marcelle Inc. c24ac3ad-b2e2-4381-bd80-a499da0e0670 2021-12-14 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65753-101-10 65753010110 7 mL in 1 POUCH 7 ml Historical 65753-101-11 65753010111 59 mL in 1 BOTTLE, SPRAY (65753-101-11) 59 ml 2019-11-22 0000-00-00 No No Current 65753-101-12 65753010112 118 mL in 1 BOTTLE, SPRAY (65753-101-12) 118 ml 2019-11-22 0000-00-00 No No Current 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 65753-101-23 65753010123 50 PACKET in 1 CONTAINER (65753-101-23) > 7 mL in 1 PACKET 50 packet 2019-11-22 0000-00-00 No No Current 65753-101-24 65753010124 50 PACKET in 1 CARTON (65753-101-24) > 7 mL in 1 PACKET 50 packet 2019-11-22 0000-00-00 No No Current 65753-101-25 65753010125 100 PACKET in 1 CARTON (65753-101-25) > 7 mL in 1 PACKET 100 packet 2019-11-22 0000-00-00 No No Current 65753-101-26 65753010126 300 PACKET in 1 BOX (65753-101-26) > 7 mL in 1 PACKET 300 packet 2019-11-22 0000-00-00 No No Current 65753-101-27 65753010127 16 PACKET in 1 BOX (65753-101-27) > 7 mL in 1 PACKET 16 packet 2018-11-22 0000-00-00 No No Current