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 153 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATTITUDE Super leaves Lip Balm SPF 15 Watermelon ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 450dcc02-8bcb-6c07-e063-6394a90a5df4 2025-12-03 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44acf513-ffe6-888c-e063-6394a90a9c5c 2025-12-03 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 450e52a9-5a6b-112f-e063-6394a90af7ca 2025-12-03 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 450e6eb7-f49e-296e-e063-6294a90a05a4 2025-12-03 Warnings Exact identifier application number: M020 Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango ZINC OXIDE 9055-7588 Qubec Inc. DBA Attitude 359a7ebf-46a6-4e99-b43c-f585e9bc08d9 2025-12-03 Warnings Exact identifier application number: M020 ATTITUDE Sunly Lip balm Unscented SPF 15 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d95a2b7-288d-7b29-e063-6294a90ae46b 2025-12-03 Warnings Exact identifier application number: M020 Attitude - Lip Balm - SPF 15 - Coconut ZINC OXIDE Attitude DBA 9055-7588 Qubec Inc. 068af2ec-a666-45bf-b0e0-89d1b93dedf1 2025-12-03 Warnings Exact identifier application number: M020 Cancer Council Invisible Fluid SPF50 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vitality US Co. 1629b02b-e9f3-0593-e063-6294a90a9aa5 2025-12-03 Warnings Exact identifier application number: M020 PRO-TECT SPORTS SUNSCREEN MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE Bio-Medical & Pharmaceutical Manufacturing Corporation 16994959-cade-06de-e054-00144ff88e88 2025-12-03 Warnings Exact identifier application number: M020 PRO-TECT SPORTS SUNSCREEN MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE Bio-Medical & Pharmaceutical Manufacturing Corporation 66bb06fb-33d2-4b57-a65f-66bcd187c627 2025-12-03 Warnings Exact identifier application number: M020 PRO-TECT SUNSCREEN FOR PROFESSIONALS MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE Bio-Medical & Pharmaceutical Manufacturing Corporation 374e172b-90e8-4fca-8934-dee3ed7b599d 2025-12-03 Warnings Exact identifier application number: M020 LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL OCTINOXATE, ZINC OXIDE BEL STAR S A 25b6cb46-6516-376a-e063-6394a90a44f6 2025-12-03 Warnings Exact identifier application number: M020 LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BEL STAR SA 4510cd0d-40b8-f452-e063-6394a90a44e5 2025-12-03 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 45117885-c674-b58a-e063-6394a90af5f4 2025-12-03 Warnings Exact identifier application number: M020 CANNON BALM OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE DUKE CANNON SUPPLY CO. f70a0173-c8ba-da7c-e053-6294a90a67db 2025-12-03 Warnings Exact identifier application number: M020 Radically Rejuvenating SPF Day Cream ZINC OXIDE Better Planet Brands LLC 1d8c8600-f2d1-6e12-e063-6294a90ab88a 2025-12-03 Warnings Exact identifier application number: M020 Seriously Soothing SPF Day Cream ZINC OXIDE Better Planet Brands LLC 1d8d47f6-907d-ab31-e063-6394a90a05d8 2025-12-03 Warnings Exact identifier application number: M020 Invisible Sunscreen Stick SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Better Planet Brands LLC 1d8df35e-0af6-36f6-e063-6394a90a0f03 2025-12-03 Warnings Exact identifier application number: M020 Sun Serum Drops ZINC OXIDE Better Planet Brands LLC 2cdb97bf-a4d7-1cb7-e063-6394a90ab2b8 2025-12-03 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 ZINC OXIDE Better Planet Brands LLC 1d8e727c-8b50-9cf2-e063-6394a90a2e15 2025-12-03 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