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 288 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bali Body Watermelon Tanning Oil SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 1fd37cec-807e-ddd3-e063-6294a90ae88e 2024-08-16 Warnings Exact identifier application number: M020 SunPlus SPF 30 Everyday Inspired Broad Spectrum Sunscreen AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC fcae486a-5ea8-4f33-98bf-ec68a13d6b8a 2024-08-15 Warnings Exact identifier application number: M020 SunPlus SPF 50 Everyday Inspired Broad Spectrum Sunscreen AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC a2a028a1-3f35-45f6-99a9-8a1c8b4c1f9b 2024-08-15 Warnings Exact identifier application number: M020 SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam up ZINC OXIDE Spigen Beauty Inc. 94c0d586-8de5-45d1-8a82-07555996e61d 2024-08-14 Warnings Exact identifier application number: M020 FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45 ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE ESTEE LAUDER INC 82db54ba-3ebd-4b70-b41c-b0d2faad7daa 2024-08-13 Warnings Exact identifier application number: M020 DERMA BRITE SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE PHARMAGEL INTERNATIONAL INC fe10912e-00e3-406c-a80c-d9c991dc9f8b 2024-08-13 Warnings Exact identifier application number: M020 SUN THERAPE FACE AND BODY SPF-35 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE PHARMAGEL INTERNATIONAL INC 6a96623f-c37c-4e67-925e-f133461d726d 2024-08-13 Warnings Exact identifier application number: M020 SUN THERAPE SPORT SPF-35 HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE PHARMAGEL INTERNATIONAL INC 0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d9 2024-08-13 Warnings Exact identifier application number: M020 Biocorneum AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE Biodermis LLC ef95f2b7-e438-4990-880d-81621edb2002 2024-08-13 Warnings Exact identifier application number: M020 TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E ZINC OXIDE Fallien Cosmeceuticals, Ltd 1f417082-5fd1-c95e-e063-6394a90a16ab 2024-08-09 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, Ltd 1f4491ab-95b0-cc14-e063-6394a90a73ca 2024-08-09 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b737146d-fb50-4ed6-ab5e-6aff3393992a 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 54b07420-6a30-4481-99f5-a7d6a4df898c 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 65659277-cd30-453c-929e-3651c9f19da8 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 28ae9c39-eb79-4a19-8149-af8d8e7901ae 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 05f7119a-0c92-4393-a62d-8e84ec451d20 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b90ee1ba-17b5-4367-9df3-e9e27217960c 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ad5c5121-d75d-449d-a4db-a7b074787f68 2024-08-06 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00 OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 0018573d-922b-4642-9513-63481e9131d5 2024-08-06 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 83b20b0d-c2db-4720-8434-57b73847ebca 2024-08-06 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