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 227 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2ee9b3dc-91cd-1af9-e063-6394a90a78e1 2025-02-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2edc79f8-aac5-15eb-e063-6394a90a9736 2025-02-23 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc25651b-0e30-c325-e053-2995a90a809e 2025-02-21 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc129cd6-a173-d2b3-e053-2a95a90aa04e 2025-02-21 Warnings Exact identifier application number: M020 COOLA Classic Liplux Lip Balm SPF 30 Tinted AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC eec6e7c8-17fe-f34b-e053-2995a90a78a0 2025-02-20 Warnings Exact identifier application number: M020 Drops AVOBENZONE OCTISALATE OCTOCRYLENE Vacation Inc. 1319d6ea-a580-79c5-e063-6394a90a4dca 2025-02-20 Warnings Exact identifier application number: M020 Vacation SPF 50 Super Spritz Face Mist AVOBENZONE, OCTISALATE, OCTOCRYLENE Vacation Inc. f67fbe98-93ce-2882-e053-2a95a90ab713 2025-02-20 Warnings Exact identifier application number: M020 REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 10edc0c1-9359-4c7a-a56e-bad06fea0056 2025-02-20 Warnings Exact identifier application number: M020 Mineral SPF 30 Brush-On Sun Defense ZINC OXIDE Mineral Fusion 29733dba-8824-461e-be44-335d6fe50d60 2025-02-19 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 20cd4d96-2046-3a50-e063-6394a90a1219 2025-02-18 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Pina Colada AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC edc59de7-c817-1a59-e053-2995a90a3408 2025-02-17 Warnings Exact identifier application number: M020 Liplux SPF 30 Lip Balm CLASSIC COOLA LLC b47b5f3a-43f3-ae7a-e053-2995a90ae16d 2025-02-17 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 50 Fragrance Free AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed207afe-0b10-74c7-e053-2a95a90a9b87 2025-02-17 Warnings Exact identifier application number: M020 Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE The Avon Company 2e5d6c93-f091-5388-e063-6394a90ad560 2025-02-17 Warnings Exact identifier application number: M020 KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE e.l.f. Cosmetics, Inc 31a98dc7-4b99-d845-e063-6394a90a2670 2025-02-17 Warnings Exact identifier application number: M020 Ultra sheer mineral sunscreen PRO SPF30 ZINC OXIDE Eden Brands Inc. 2ce06566-2eb0-9a00-e063-6394a90a9ba9 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2dff0386-e151-089a-e063-6394a90a0f53 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CMS LAB Inc. 2dffc699-3b56-2c70-e063-6294a90ae249 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Sheer) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2082aa-5ae3-2c04-e063-6294a90a140b 2025-02-14 Warnings Exact identifier application number: M020 Coola SPF 30 Mineral Sunscreen Fragrance Free ZINC OXIDE COOLA, LLC edc6048e-0ea0-41c5-e053-2a95a90a96d9 2025-02-14 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