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 286 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bright as Day Mineral SPF50 ZINC OXIDE Koco Life LLC 1c245a53-4098-62e6-e063-6294a90abf12 2024-09-23 Warnings Exact identifier application number: M020 Pure Protect Mineral Sunscreen Stick SPF50 ZINC OXIDE Koco Life LLC 22cd5999-9b9a-91a3-e063-6394a90a0da5 2024-09-23 Warnings Exact identifier application number: M020 ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Absolutely Natural eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea 2024-09-23 Warnings Exact identifier application number: M020 SUNSCREEN 01 AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE Cosmuses Cosmetics (Ningbo) Co., Ltd. 229dabbc-9043-3c9d-e063-6394a90a5692 2024-09-21 Warnings Exact identifier application number: M020 GLC OG Natural Tinted SPF 30 Sunscreen ZINC OXIDE GUD LIFE CO. LLC 25e1e8ec-e19d-45f7-b339-5d12c2b511d6 2024-09-18 Warnings Exact identifier application number: M020 Target Up and Up Sunscreen SPF 30 SPORT Broad Spectrum AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE TARGET CORPORATION bad7d56e-662e-0776-e053-2a95a90a0af0 2024-09-18 Warnings Exact identifier application number: M020 Target Up and Up Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION b82b6d0d-616d-f041-e053-2995a90ae6a3 2024-09-18 Warnings Exact identifier application number: M020 COOLA Dew Good Illuminating Body Melt SPF 40 AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA LLC 43d293f6-e13c-4ee9-89df-2a3ef0034e31 2024-09-16 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO non-tinted replenishing daily protection ZINC OXIDE Fallien Cosmeceuticals, Ltd 2203ea22-d12a-99fe-e063-6394a90aca9f 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Tinted ZINC OXIDE Allure Labs 22042031-ac8e-1ab2-e063-6394a90a6ed4 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Tinted ZINC OXIDE ONESKIN INC. 2204e776-b1a1-be15-e063-6294a90af5de 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Untinted ZINC OXIDE Allure Labs 2205345b-5e92-37eb-e063-6294a90a6b6c 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Untinted ZINC OXIDE ONESKIN INC. 2205ec0e-ac3f-299f-e063-6294a90a2174 2024-09-13 Warnings Exact identifier application number: M020 H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f4130277-ea9b-6b25-e053-2a95a90a59be 2024-09-13 Warnings Exact identifier application number: M020 HEB SPF 50 Tattoo Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f6df491d-1fa9-a4c8-e053-6394a90a3866 2024-09-13 Warnings Exact identifier application number: M020 YOUR Day Cream Sunscreen Broad Spectrum SPF 30 OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE Skin Ai, LLC 21cbd5ac-5307-939b-e063-6294a90ac791 2024-09-10 Warnings Exact identifier application number: M020 Mario Badescu SPF 17 AVOBENZONE, OCTINOXATE, OCTOCRYLENE Bentley Laboratories LLC 0fd51f8d-ee67-48fd-ab98-1fedb0339462 2024-09-10 Warnings Exact identifier application number: M020 Mario Badescu Collagen SPF 15 AVOBENZONE, OCTINOXATE, OXYBENZONE Bentley Laboratories LLC 0246b11b-f1ba-4f47-91ab-52a6554b9467 2024-09-10 Warnings Exact identifier application number: M020 Mario Badescu The Moisture Magnet SPF 15 AVOBENZONE, OCTINOXATE, OXYBENZONE Bentley Laboratories LLC f6d653f5-52a0-42ad-8308-b8d6f57050cc 2024-09-10 Warnings Exact identifier application number: M020 MARIO BADESCU SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Bentley Laboratories LLC fe485d4c-0ded-4061-ac34-77b72d535090 2024-09-10 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