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 228 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COOLA Classic Body SPF 50 Guava Mango AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed13afaa-35ec-8326-e053-2995a90adaf0 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Light) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e21f5bb-e7df-b43b-e063-6394a90a0f82 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Fair) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2102c6-02ea-3a8f-e063-6394a90abf5e 2025-02-14 Warnings Exact identifier application number: M020 Sunscreen Broad Spectrum SPF 50 Vi Aesthetics ZINC OXIDE, OCTINOXATE Vi Medical Products, INC 73620765-c7c0-4bd7-82a9-00022773c928 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2297d4-3649-a749-e063-6294a90ac284 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Light) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e22cfde-10a1-3742-e063-6394a90ac097 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2e5c2add-8ed0-a990-e063-6394a90a87ea 2025-02-14 Warnings Exact identifier application number: M020 Les Duets - Shield of Helios, sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f75a5-6a3b-a129-e063-6394a90a52a0 2025-02-14 Warnings Exact identifier application number: M020 Le Mieux Naked Glow Bronzer SPF 50 SUNSCREEN YB CHEMIA LLC 46465db7-c1f0-6980-e063-6294a90a3ed8 2025-02-14 Warnings Exact identifier application number: M020 Sheer Tint Mineral SPF Serum - Light Light ZINC OXIDE Mineral Fusion brands ac6fdc35-82f8-4805-875e-2aa91aedec6f 2025-02-14 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 50 ZINC OXIDE Peer Pharm Ltd. 3989eebc-7262-4cda-84a1-ca30b638b772 2025-02-13 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 30 ZINC OXIDE Peer Pharm Ltd. 8ee9f97b-9081-4e0c-aa7a-27a31cbee17a 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Medium Deep ZINC OXIDE Peer Pharm Ltd. 45ed56e1-46cb-46de-b11a-e814a7446e57 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Light Medium ZINC OXIDE Peer Pharm Ltd. 6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Dry Touch SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC e99311c2-ed8b-6e60-e053-2a95a90a9bc2 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 525f7bae-44b8-44e4-93ea-32995eca2566 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen Sunlit SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e093b82-2a36-cc0f-e063-6394a90a4d6d 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC f93b0091-6a41-ae6e-e053-6394a90a86d7 2025-02-13 Warnings Exact identifier application number: M020 Revealer Skin-Improving Foundation SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e0a0cd6-c302-2017-e063-6394a90a60b8 2025-02-13 Warnings Exact identifier application number: M020 Hi papa KIDS MINERAL FACE SUNSCREEN SUNSCREEN GUANG DONG 3 INS TECHNOLOGY Co., Ltd 2deea723-32a0-da33-e063-6294a90accdd 2025-02-12 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