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 116 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE SAN JOSE MEDICAL SPA 37ef19e5-1775-a8d5-e063-6394a90acaef 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE, TITANIUM DIOXIDE BABYFACE LLC 36d69eb5-59b4-14a0-e063-6394a90a0a49 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d6141c-6967-d779-e063-6294a90af0a7 2025-12-16 Exact identifier application number: M020 Replenishing Daily Sunscreen ZINC OXIDE BABYFACE LLC 36d773d7-349d-68c1-e063-6394a90aff1e 2025-12-16 Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Light ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d44158a-44b3-5a3d-e063-6294a90a1f16 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Light-Medium ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d53071f-0275-d00c-e063-6294a90afcca 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Medium ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d550967-25af-3e7a-e063-6394a90a2c79 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Medium-Deep ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d57790c-22cf-08aa-e063-6394a90aeac0 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Deep ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d5813e8-a219-db90-e063-6294a90a6ca7 2025-12-16 Warnings Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c043e0-fd6c-5f7a-e063-6294a90a8899 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0c1ca-80a8-9d37-e063-6294a90a824f 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0f5df-6bfb-3c0d-e063-6294a90a2e5f 2025-12-16 Exact identifier application number: M020 Daily Protect Mineral Sunscreen ZINC OXIDE SARAH'S 4617beb7-381e-8994-e063-6394a90a14b5 2025-12-16 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT ENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDE Shiseido Americas Corporation 8db9f5e0-a8d6-4872-b4c6-cb92c43d25c2 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE N AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Shiseido Americas Corporation 18ed9b7f-bdbe-45d7-a38c-6d065080ae99 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE FOR BODY N ENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Shiseido Americas Corporation a2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c 2025-12-16 Warnings Exact identifier application number: M020 b.tan Beach Please SPF 7 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Marque of Brands Americas, LLC bdc07d83-a34f-5262-e053-2995a90acfc3 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 461910bd-1f74-f99e-e063-6394a90ae30e 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 4619b08f-3e63-25aa-e063-6294a90a78d7 2025-12-16 Warnings Exact identifier application number: M020 meg ALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48 Meg Cosmetics Inc 4526bacf-6451-b297-e063-6294a90af71a 2025-12-16 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