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 322 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join YOU-V SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE YouV, LLC 290cd617-aa90-4f10-8a1d-d8954b927004 2023-11-11 Warnings Exact identifier application number: M020 BEAST SPIT and POLISH FACE SPF-20 OCTOCRYLENE, OCTISALATE, AVOBENZONE Small Batch Beauty, LLC 27e5244b-4b69-4dec-9dd5-ba8b71b171b2 2023-11-11 Warnings Exact identifier application number: M020 SEVEN MINERALS Skin Friendly SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE Seven Minerals NA LLC bd60cf89-e0e9-48ad-b174-1ecf72557d9c 2023-11-11 Warnings Exact identifier application number: M020 OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 743f3d23-0f5c-4724-9f69-411c109506e1 2023-11-11 Warnings Exact identifier application number: M020 SEVEN MINERALS Skin Friendly SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Seven Minerals NA LLC 6d6b5b2a-210a-4606-9cdb-f6eec10f37e8 2023-11-11 Warnings Exact identifier application number: M020 KISS MY FACE SPF-50 Baby Mineral Sunscreen ZINC OXIDE WINDMILL HEALTH PRODUCTS LLC ac66ad82-a01f-4e44-92a7-b5ab5bd30922 2023-11-11 Warnings Exact identifier application number: M020 KISS MY FACE SPF-50 Daily Mineral Sunscreen ZINC OXIDE WINDMILL HEALTH PRODUCTS LLC 1745dc35-648e-4315-a285-c99ebeef4f6a 2023-11-11 Warnings Exact identifier application number: M020 KISS MY FACE SPF-50 Face Factor Mineral Sunscreen ZINC OXIDE WINDMILL HEALTH PRODUCTS LLC edc2c1e7-e1a8-4b49-96df-8a94eb6a242a 2023-11-11 Warnings Exact identifier application number: M020 ONCODERM Rx Mineral Sunscreen SPF-30 TITANIUM DIOXIDE, ZINC OXIDE Oncoderm, LLC 9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae 2023-11-11 Warnings Exact identifier application number: M020 SEAWEED BATH CO. SPF 50 SPORT OCTOCRYLENE, ZINC OXIDE, OCTISALATE The Seaweed Bath Co. f01516bf-8aed-4402-a3f9-ef11c54d46b3 2023-11-11 Warnings Exact identifier application number: M020 SEAWEED BATH CO. SPF-30 OCTOCRYLENE, ZINC OXIDE, OCTISALATE The Seaweed Bath Co. 4df55434-fb9a-442d-82cf-16a4957f0a2a 2023-11-11 Warnings Exact identifier application number: M020 PROJECT REEF Mineral Sunscreen SPF-30 ZINC OXIDE Project Reef LLC b7de9ec2-6db1-4c89-b734-15c4bd5c3251 2023-11-11 Warnings Exact identifier application number: M020 SEAWEED BATH CO Cooling Mist SPF-60 Sport HOMOSALATE, OCTISALATE, ZINC OXIDE The Seaweed Bath Co. 98ccbb70-6e1a-4e92-a095-cbc4be12fcbf 2023-11-11 Warnings Exact identifier application number: M020 PROJECT REEF Mineral Sunscreen SPF-50 ZINC OXIDE, TITANIUM DIOXIDE Project Reef LLC 87b9170c-956e-4aa2-9416-da00cca81b58 2023-11-11 Warnings Exact identifier application number: M020 YOUTH CORRIDOR Soothe and Defend SPF-30 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Youth Corridor 5c0873ff-8e76-48de-919d-f69794c4bd37 2023-11-11 Warnings Exact identifier application number: M020 ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50) HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE ZITSTICKA, Inc 32164318-7a7e-40b2-99da-8246c99fdbd3 2023-11-11 Warnings Exact identifier application number: M020 SUNNY Q Broad Spectrum SPF-30 ZINC OXIDE Sunny Q Sunscreen LLC 593870fa-425c-401c-ac26-f63f4ce0298f 2023-11-11 Warnings Exact identifier application number: M020 BRICKELL Daily Defense Face Moisturizer SPF-20 OCTISALATE, ZINC OXIDE BRICKELL BRANDS LLC 44806b83-9220-4d34-806d-20cf0a47186e 2023-11-11 Warnings Exact identifier application number: M020 BRICKELL Element Defense Moisturizer SPF-45 OCTOCRYLENE, OCTISALATE, ZINC OXIDE BRICKELL BRANDS LLC 94be278a-3773-469b-8e40-3242d1072a3d 2023-11-11 Warnings Exact identifier application number: M020 I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream AVOBENZONE, OCTISALATE, OCTOCRYLENE Thirty7 LLC 6ff00b6e-1cc7-4cc4-842b-4e379f75e454 2023-11-11 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