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 213 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Melan Antioxidant Body Mist Sunscreen SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE MELAN INC. f627b17f-d2dc-47bd-b865-08995995e861 2025-05-20 Warnings Exact identifier application number: M020 JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. 63e078a3-d5df-4458-a745-e306d734e6be 2025-05-20 Warnings Exact identifier application number: M020 JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREEN AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. 90531e8f-15c6-49ac-96a4-3bdfab2bfd9b 2025-05-20 Warnings Exact identifier application number: M020 JAFRA BIOLAB SUNSCREENS AND CLEANSER AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. 28db9f44-780f-4cd5-940e-3ee779f38247 2025-05-20 Warnings Exact identifier application number: M020 Mineral Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE IT INTELLIGENT TREATMENT LLC 3595149d-0735-6bea-e063-6394a90a618a 2025-05-20 Exact identifier application number: M020 Mineral Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE IT INTELLIGENT TREATMENT LLC 3595735e-c25f-eb48-e063-6294a90aac0f 2025-05-20 Exact identifier application number: M020 Coola Clear California Summers OCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATE COOLA, LLC 358009c4-492d-ac03-e063-6294a90af227 2025-05-19 Warnings Exact identifier application number: M020 OS-01 FACE SPF BS SPF 30 TINTED DEEP ZINC OXIDE ONESKIN INC. 3581f578-e19e-9ace-e063-6294a90acc34 2025-05-19 Warnings Exact identifier application number: M020 No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 351251f5-e656-98b6-e063-6394a90ad805 2025-05-14 Warnings Exact identifier application number: M020 No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 35129e6f-c6bd-a9f7-e063-6394a90ab0e4 2025-05-14 Warnings Exact identifier application number: M020 Noevir Raysela UV Shield Primer ZINC OXIDE, OCTINOXATE Nippon Shikizai, Inc. 45030b2f-21cf-4285-af12-87ea8f0b8df7 2025-05-14 Warnings Exact identifier application number: M020 OS-01 Lip SPF BS SPF15 ZINC OXIDE ONESKIN INC. 351d55f6-fcd9-1d47-e063-6294a90a2cf0 2025-05-14 Warnings Exact identifier application number: M020 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM Port Jervis Laboratories, Inc. 350cd329-8fe2-314f-e063-6394a90ac954 2025-05-13 Warnings Exact identifier application number: M020 Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30 ZINC OXIDE Lancer Skincare LLC 522a9158-2fd1-4634-adef-2ba84c86bcd7 2025-05-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Navajo Manufacturing Company Inc. 33f13aa4-9279-c251-e063-6294a90a2d67 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BS SPF 30 TINTED DEEP ZINC OXIDE Allure Labs 34f51ff4-541d-2b2e-e063-6394a90a39da 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Natural SPF 30 ZINC OXIDE Renu Laboratories, LLC e7035fcd-6894-3360-e053-2a95a90a6f1d 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Sport SPF ZINC SPF RENU LABORATORIES, LLC c9b48a9e-d69f-65a7-e053-2995a90a0baf 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP ZINC OXIDE Allure Labs 34f674c1-5d59-915a-e063-6394a90a6c2f 2025-05-12 Warnings Exact identifier application number: M020 Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE Meaningful Beauty, LLC f59fe019-569b-49ba-accf-fa4d356ce96b 2025-05-12 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