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 279 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef Friendly AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE THE KROGER COMPANY c706aaf0-a978-7848-e053-2995a90a0aca 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC c51029f4-ede0-08ef-e053-2995a90aecaf 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, TOPCO ASSOCIATES LLC c8af028e-9d68-4023-e053-2995a90ad18a 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c5601d22-2353-7319-e053-2a95a90a16c0 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c8c12a5a-59f5-6515-e053-2995a90a58f7 2024-10-15 Warnings Exact identifier application number: M020 Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c6268778-8dcc-24b6-e053-2995a90acf03 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Sun SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f0de2999-f12b-89b1-e053-2a95a90ac610 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50 ZINC OXIDE TOPCO ASSOCIATES LLC d501a94e-3bcd-d8e4-e053-2a95a90a33b0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Kids Mineral Sunscreen ZINC OXIDE TOPCO ASSOCIATES LLC dbee42c8-9cae-7a81-e053-2a95a90a2329 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Sun Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f12c09b1-8ffe-4933-e053-2995a90a434f 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC dbf03882-ab1a-9805-e053-2995a90a7109 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula TITANIUM DIOXIDE, ZINC OXIDE TOPCO ASSOCIATES LLC f14f43e6-ee57-5495-e053-2a95a90a4011 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Continuous Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC f31ea60e-1f52-c55f-e053-2a95a90afe64 2024-10-15 Warnings Exact identifier application number: M020 Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC f71e019b-392a-f8eb-e053-6394a90a871e 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC a5b06600-f2b0-6d9b-e053-2995a90a59f0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultra Protection Sun SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f41d4c46-7998-afe6-e053-2995a90ab361 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 OCTISALATE, ZINC OXIDE TOPCO ASSOCIATES LLC f71c9060-3daf-e1be-e053-6294a90a4f91 2024-10-15 Warnings Exact identifier application number: M020 MINERAL SUNSCREEN SPF 50 ZINC OXIDE, TITANIUM DIOXIDE TOPCO ASSOCIATES LLC bfe076fa-f21f-2c46-e053-2a95a90acee4 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Mineral Sunscreen Stick ZINC OXIDE H.E.B. f58f0199-bf22-2197-e053-2995a90ae64f 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented ZINC OXIDE H.E.B. f58d328c-8b30-b4d4-e053-2a95a90adb59 2024-10-15 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