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 254 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BABYGANICS SPF 50 Plus SUNSCREEN ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE KAS Direct LLC dba Babyganics 4075f9dc-c25f-434f-a3fc-a7f896295c3d 2024-12-20 Warnings Exact identifier application number: M020 Sunscreen HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE Total Resources International 7d4f820d-e154-428e-89c2-2e26e088ceef 2024-12-20 Warnings Exact identifier application number: M020 Babyganics Sheer Blend SPF50 Mineral Sunscreen ZINC OXIDE KAS Direct LLC dba BabyGanics edced0dc-dd43-4ac9-b816-f4edb45fc87b 2024-12-20 Warnings Exact identifier application number: M020 NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE COSMAX USA, CORPORATION 29ad7391-d932-3549-e063-6394a90ab2b2 2024-12-20 Warnings Exact identifier application number: M020 Face Reality daily spf 30 plus Sunscreen SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE Face Reality,LLC 45a3ce12-15fe-4040-95da-ac8513a39fb9 2024-12-20 Warnings Exact identifier application number: M020 Face Reality mineral matte spf 28 Sunscreen SPF 28 ZINC OXIDE, TITANIUM DIOXIDE Face Reality, LLC 29b70afe-cf9d-d0ba-e063-6394a90a1cc4 2024-12-20 Warnings Exact identifier application number: M020 Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted Moisturizer ZINC OXIDE ASA Universal Inc. dba: Sonage fd14d70c-6cd0-5de6-e053-6294a90a7add 2024-12-20 Warnings Exact identifier application number: M020 Coola SPF 50 Classic SUNSCREEN FACE MIST COOLA LLC d18d0dac-5690-436e-e053-2995a90a0254 2024-12-20 Warnings Exact identifier application number: M020 COOLA Mineral Body SPF 30 Tropical Coconut ZINC OXIDE COOLA, LLC eeb5d4f1-8cba-9ef6-e053-2a95a90a823f 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Oars and Alps LLC f3971b85-a13e-4195-e053-2995a90a73cb 2024-12-20 Warnings Exact identifier application number: M020 Vacation SPF 30 Mineral ZINC OXIDE Vacation Inc. f69513ae-f210-075f-e053-2a95a90a9b2e 2024-12-20 Warnings Exact identifier application number: M020 Vacation SPF 30 Chardonnay Oil AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f694752d-4839-3768-e053-2995a90a5d3e 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSpray AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Oars and Alps LLC ec5b82f5-b36c-fbc5-e053-2995a90afa0c 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 70 Hydrating Antioxidant Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Oars and Alps LLC f39673a7-0b62-bdf7-e053-2995a90aa2b7 2024-12-20 Warnings Exact identifier application number: M020 Carpe SPF 30 Face Primer TITANIUM DIOXIDE, ZINC OXIDE Clutch, Inc. DBA Carpe feac5ee2-faa5-fd17-e053-6394a90a7f99 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 Mineral ZINC OXIDE Oars and Alps LLC f395bc39-daa5-53b8-e053-2995a90a5f48 2024-12-20 Warnings Exact identifier application number: M020 Babyganics Kids Sheer Blend SPF50 Mineral Sunscreen ZINC OXIDE KAS Direct LLC dba BabyGanics 8a143645-3b52-4797-9b26-dc9dd63be38f 2024-12-20 Warnings Exact identifier application number: M020 Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Small World Brands b1df4c81-333b-450d-963e-6670ab9bbda9 2024-12-20 Warnings Exact identifier application number: M020 foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beige TITANIUM DIOXIDE AND ZINC OXIDE Tarte, Inc. 062fa0d9-f384-48af-8269-42de3a788db1 2024-12-20 Warnings Exact identifier application number: M020 Stokoderm Sunscreen PURE AVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATE SC Johnson Professional USA, Inc. 3ddf81e6-de78-4f2f-814b-c75eadcddb39 2024-12-20 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