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 237 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Baby Donna SHeer SPF Sunscreen Stick ZINC OXIDE Stream2Sea, LLC a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe 2025-01-12 Warnings Exact identifier application number: M020 SUN PROTECT LIP BALM SPF 30 ZINC OXIDE AND TITANIUM DIOXIDE Stream2Sea, LLC 21386652-b952-48be-b077-1acecc7f0eb0 2025-01-12 Warnings Exact identifier application number: M020 Equate Beauty Daily Moisturizer SPF-30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Wal-Mart Stores, Inc. 00abd6d0-c467-4885-80fe-b062622147d7 2025-01-10 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. 2b5aebed-49f6-7bb8-e063-6294a90a8521 2025-01-10 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Drops Face Serum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. 2b5c69e4-2819-94ef-e063-6394a90a68e7 2025-01-10 Warnings Exact identifier application number: M020 Dermaroller Anhydrous Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Owen Biosciences, Inc. 04e82f1b-c893-4795-b7a9-0523e3ec7552 2025-01-10 Warnings Exact identifier application number: M020 Skinfuse Shield SPF 30 ZINC OXIDE Owen Biosciences, Inc. b8e4c11a-4b4f-4e36-a75e-0a73913113d5 2025-01-10 Warnings Exact identifier application number: M020 Correct and Protect Serum Broad Spectrum SPF 45 ZINC OXIDE Murad, LLC 60c62108-6806-4722-a44b-f1c300d59c1e 2025-01-10 Warnings Exact identifier application number: M020 Multi Vitamin Clear Coat Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Murad, LLC e023c874-c89d-4bd0-a0b9-a8161c261457 2025-01-10 Warnings Exact identifier application number: M020 CoTZ Baby ZINC OXIDE Fallien Cosmeceuticals, LTD 17cc12c7-5af8-413f-b205-31ac150583e2 2025-01-09 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID DAILY SUNGEL AVOBENZONE, HOMOSALATE, OCTISALATE ISNTREE Inc. 2b3bdbe1-ede9-cd60-e063-6394a90ab2f3 2025-01-09 Warnings Exact identifier application number: M020 JAFRA ROYAL REVITALIZE 4 TUBE SET AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98 2025-01-09 Warnings Exact identifier application number: M020 glo SKIN BEAUTY Moisturizing Tint SPF 30 GLO SKIN BEAUTY MOISTURIZING TINT SPF 30 Hayden Caleel LLC 2b464a70-8f40-3148-e063-6394a90ac18c 2025-01-09 Warnings Exact identifier application number: M020 Sunscreen and insect repellent Bull frog SPF 50 Bullfrog Brands, LLC d65d15a6-0a32-1203-e053-2995a90aa6c5 2025-01-09 Warnings Exact identifier application number: M020 Sunscreen and insect repellent Bull frog SPF 50 Bullfrog Brands, LLC d5fb3632-24da-2c7a-e053-2a95a90a5081 2025-01-09 Warnings Exact identifier application number: M020 Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE NEW SEASON DERMATOLOGY, PLLC fecd72a3-c7e5-3dfa-e053-6394a90a7357 2025-01-09 Warnings Exact identifier application number: M020 ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 41b3cf18-dc11-4e1d-802e-5ba25bd87adb 2025-01-09 Warnings Exact identifier application number: M020 ECLIPSE SPF 50 PERFECTINT BEIGE TITANIUM DIOXIDE, ZINC OXIDE SCIENCE OF SKINCARE LLC b69dda25-372f-15d9-e053-2995a90a8d3e 2025-01-09 Warnings Exact identifier application number: M020 PerfecTint Powder SPF 40 All Shades ZINC OXIDE Science of Skincare bb26c010-299e-3dc5-e053-2995a90a2c89 2025-01-09 Warnings Exact identifier application number: M020 Extreme Protect SPF 40 All Shades ZINC OXIDE, TITANIUM DIOXIDE Science of Skincare, LLC. b69db78b-5f0e-8ca2-e053-2a95a90ac88c 2025-01-09 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