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 326 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3W OCTISALATE, TITANIUM DIOXIDE Guerlain 15fe0429-720c-4975-953d-285aa7ee12ce 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4W OCTISALATE, TITANIUM DIOXIDE Guerlain 1a733548-75a4-41ec-8d8d-3e6e9aad52e0 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8N OCTISALATE, TITANIUM DIOXIDE Guerlain f43c867a-161f-47b7-b3d8-7f7e6c672804 2023-11-08 Warnings Exact identifier application number: M020 Aruba Sun SPF 70 Sunscreen AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% Derma Care Research Labs, LLC d96b4233-6d52-7621-e053-2a95a90a1b60 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C OCTISALATE, TITANIUM DIOXIDE Guerlain 0d75be99-7607-4964-bb6e-3c731644ab4e 2023-11-08 Warnings Exact identifier application number: M020 Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE AHAVA Dead Sea Laboratories Ltd dee4bdb8-5c6f-42f6-b15c-d109cd2d3140 2023-11-08 Warnings Exact identifier application number: M020 Mineral Radiance Energizing Day BS SPF 15 AVOBENZONE, HOMOSALATE, AND OCTISALATE AHAVA Dead Sea Laboratories Ltd 4cb8b21c-7727-441a-9d61-c90d79ac45dc 2023-11-08 Warnings Exact identifier application number: M020 Jack Black Intense Therapy Lip Balm Passion Fruit AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN Jack Black, LLC f34beb68-e5dc-45c4-a6d1-e9a031016228 2023-11-08 Warnings Exact identifier application number: M020 Private Label SPF45 Water Resistant Paraben Free Sunscreen OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN Swiss-American CDMO, LLC f997f4fc-7da5-433c-9a53-2030b489b4f6 2023-11-07 Warnings Exact identifier application number: M020 Private Label Moisturizing Oil Free Paraben Free SPF43 SUNSCREEN Swiss-American CDMO, LLC 003e4221-f9d9-47c4-b10b-9876046b931a 2023-11-07 Warnings Exact identifier application number: M020 AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15 AVOBENZONE, OCTISALATE, AND OCTOCRYLENE AHAVA Dead Sea Laboratories Ltd 5a9ec221-a9ec-4473-8fb0-83f10ae775e2 2023-11-07 Warnings Exact identifier application number: M020 Private Label Super Light Oil-Free SPF45 2.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREEN Swiss-American CDMO, LLC 6a08448a-46bc-4330-ae2d-f716bb4edfa7 2023-11-07 Warnings Exact identifier application number: M020 GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE TT Fitness, Inc 617ef3af-4203-4664-b714-1b5fab2e0ee6 2023-11-06 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Clear Moisture Mineral SPF-30 ZINC OXIDE The Seaweed Bath Co. c241261c-d887-4ac2-89ce-93dcc0fce267 2023-11-06 Warnings Exact identifier application number: M020 JESS BEAUTY Let It Sun Sunscreen SPF-50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE JESS BEAUTY PRODUCTS LLC 88628c11-dbc7-4404-9701-7944a685a13d 2023-11-06 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50 ZINC OXIDE The Seaweed Bath Co. fdcfc7eb-da33-4461-a4f9-fe97ea6b873f 2023-11-06 Warnings Exact identifier application number: M020 SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42 TITANIUM DIOXIDE, ZINC OXIDE SANTO REMEDIO LLC 82d210bc-b7ca-4d74-be58-85f175a75058 2023-11-06 Warnings Exact identifier application number: M020 CALIFORNIA MANGO SPF-50 SUNSCREEN AVOBENZONE, OCTISALATE, OCTOCRYLENE CALMANGO, INC 183e523a-93ee-47ec-8bd4-5557af449ea5 2023-11-06 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF-30 TITANIUM DIOXIDE, ZINC OXIDE NEWCO LLC fa3c73a3-0dfb-4673-822a-45d946dee260 2023-11-06 Warnings Exact identifier application number: M020 JESS BEAUTY Sun Drops Sunscreen Oil SPF-50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE JESS BEAUTY PRODUCTS LLC 4e05e9d6-5127-44ca-a331-3004b2ddb534 2023-11-06 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