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 290 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clarity Rx Pucker Power lip plumper SPF 30 HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE Topiderm, Inc. 92504982-fe0e-404d-b7cf-f6b340b89802 2024-07-31 Warnings Exact identifier application number: M020 Essential Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 2132dc18-85ee-4449-86d2-d9f698f286c6 2024-07-31 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO tinted foaming mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, Ltd 1e78109f-4d2e-2705-e063-6294a90a5ad3 2024-07-30 Warnings Exact identifier application number: M020 Replenix Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4 2024-07-29 Warnings Exact identifier application number: M020 Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATE Dr Pawpaw Limited f2628e3e-9eb0-49cb-91a6-d15c48cb8a19 2024-07-25 Warnings Exact identifier application number: M020 Thinksport Daily Face SPF 50 ZINC OXIDE thinkOperations,LLC b2422785-bd35-4248-a68f-fb4b1492a4cd 2024-07-24 Warnings Exact identifier application number: M020 Thinkbaby Clear Zinc SPF 30 ZINC OXIDE thinkOperations,LLC 7cd9c971-5556-42dc-af7b-3a88221b8c94 2024-07-24 Warnings Exact identifier application number: M020 ISNTREE ONION NEWPAIR SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 0f072099-d57d-4dc4-e063-6394a90ab438 2024-07-23 Warnings Exact identifier application number: M020 ISNTREE ONION NEWPAIR SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 14b11b42-d1fe-572f-e063-6394a90a9eec 2024-07-23 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide ZINC OXIDE Fallien Cosmeceuticals, Ltd 1dda8259-4121-3c76-e063-6394a90af189 2024-07-22 Warnings Exact identifier application number: M020 Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Eco Lips. Inc. e64c8644-7af4-7b7f-e053-2995a90af711 2024-07-22 Warnings Exact identifier application number: M020 Thinksport SPF 30 ZINC OXIDE thinkOperations,LLC 2cecda56-4860-4d35-abc2-2bb9bdf35eae 2024-07-19 Warnings Exact identifier application number: M020 CVS Health SPORT SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE CVS PHARMACY f0e8c724-b377-5dc0-e053-2995a90a0d54 2024-07-18 Warnings Exact identifier application number: M020 EQUATE Sunscreen SPORT Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE WAL-MART STORES INC 4d819fd3-de12-4394-82f4-a48faf0b7092 2024-07-18 Warnings Exact identifier application number: M020 Big Lots Soundbody SPF 30 Ultra Sport Sunscreen AVOBENZONE HOMOSALATE OCTOCRYLENE BIG LOTS STORES, INC. f0e82a9f-17ac-b1c5-e053-2995a90ae07a 2024-07-18 Warnings Exact identifier application number: M020 Equaline SPORT Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE United Natural Foods, Inc. dba UNFI f0e8dfd4-a77c-6384-e053-2a95a90a1e4a 2024-07-18 Warnings Exact identifier application number: M020 TopCare Everyday SPORT Sun Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE TOPCO ASSOCIATES LLC f0e93aa8-1b09-1312-e053-2a95a90a7934 2024-07-18 Warnings Exact identifier application number: M020 Safeway Signature Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE Safeway, Inc. f557a3e2-e415-1b65-e053-2995a90a987a 2024-07-18 Warnings Exact identifier application number: M020 Target Up and Up Sunscreen Sport Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE TARGET CORPORATION bad60bc1-cf78-7a33-e053-2995a90afdc3 2024-07-18 Warnings Exact identifier application number: M020 Scar Gel SPF 35 ZINC OXIDE derma e 8cd263aa-a54b-4c55-b3e2-6f6763987d4a 2024-07-17 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