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 110 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mattifying Mineral SPF40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d4f6a7-1115-1efa-e063-6294a90a20c4 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d69eb5-597d-14a0-e063-6394a90a0a49 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d45700-fc41-ef54-e063-6394a90abcc3 2025-12-17 Exact identifier application number: M020 Gentle Mineral SPF 40 Tinted ZINC OXIDE ELIZA ARAKELIAN 36d66cde-1f90-32b5-e063-6294a90acb34 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d7148b-b1c4-a6a9-e063-6294a90af92f 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d85902-fbd2-ba74-e063-6294a90acfc3 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad1330-a8bf-e8f8-e063-6394a90acb02 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d9a8f3-7760-57f3-e063-6394a90a1a1e 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d7a18b-5a12-84a9-e063-6394a90a7e38 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TINTED TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad4442-e45f-90e2-e063-6294a90aeef5 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d8b849-cf73-e008-e063-6394a90a410a 2025-12-17 Exact identifier application number: M020 TINTED RESTORATIVE MOISTURIZER ZINC OXIDE SKINERGIX LLC 3636adf0-c3bd-7422-e063-6394a90aaccc 2025-12-17 Exact identifier application number: M020 Premier Zinc ZINC OXIDE ENSO SKINCARE & WELLNESS LLC 3bb378c8-14b0-aa13-e063-6294a90a4db3 2025-12-17 Warnings Exact identifier application number: M020 Protect and Renew ZINC OXIDE ENSO SKINCARE & WELLNESS LLC 3bb479ed-1153-8e80-e063-6294a90a2937 2025-12-17 Warnings Exact identifier application number: M020 Flawless Finish TITANIUM DIOXIDE, ZINC OXIDE ENSO SKINCARE & WELLNESS LLC 3b8df7ce-e5ce-aaf8-e063-6394a90afdae 2025-12-17 Warnings Exact identifier application number: M020 Shield Mineral Sunscreen Tinted ZINC OXIDE SMOOTHE LLC 369b9d76-f6c3-e25f-e063-6294a90adaf3 2025-12-17 Exact identifier application number: M020 Shield Mineral Sunscreen Non Tinted ZINC OXIDE SMOOTHE LLC 369bc20d-7192-7c0a-e063-6294a90a3dfe 2025-12-17 Exact identifier application number: M020 Lip Balm TITANIUM DIOXIDE, ZINC OXIDE PATRICIA SOLIS MAKEUP ARTIST, LLC 369d63a9-b9a9-9530-e063-6394a90ac8ef 2025-12-17 Exact identifier application number: M020 Matte Tint TITANIUM DIOXIDE, ZINC OXIDE PATRICIA SOLIS MAKEUP ARTIST, LLC 369ced69-59b4-0f3c-e063-6294a90a582f 2025-12-17 Exact identifier application number: M020 Hydra Tint ZINC OXIDE PATRICIA SOLIS MAKEUP ARTIST, LLC 369d4e7a-8356-8f15-e063-6394a90acca8 2025-12-17 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