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 261 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29227121-e579-8eea-e063-6394a90a302f 2024-12-13 Warnings Exact identifier application number: M020 BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONE Bobbi Brown Professional Cosmetics Inc. 03372376-ef03-943d-e063-6394a90a52ee 2024-12-13 Warnings Exact identifier application number: M020 WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE Bobbi Brown Professional Cosmetics Inc. fbd04b66-738b-2762-e053-6394a90a8b72 2024-12-13 Warnings Exact identifier application number: M020 Mentholatum Natural Ice Cherry DIMETHICONE, OCTINOXATE, OCTISALATE The Mentholatum Company 33f43f14-8e0b-41b1-8ad0-5723d2a7bf19 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 8 Sunscreen ZINC OXIDE Absolutely Natural a26217cf-22ab-4c39-980a-b73467e16b91 2024-12-13 Warnings Exact identifier application number: M020 Calming Primer SPF 20 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience d681cdb5-307e-4a2a-8e1d-2b29131d48d0 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Absolutely Natural 8084a3ee-fe31-4cb4-8d3c-e4035d29e561 2024-12-13 Warnings Exact identifier application number: M020 Mineral Corrector Palette SPF 20 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Colorescience ab70122f-bd68-4781-841f-dc83284e1403 2024-12-13 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 0a0654cc-ad47-2167-e063-6294a90a52f4 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40 ZINC OXIDE, TITANIUM DIOXIDE Babo Botanicals, Inc. f8adda52-e909-1905-e053-6294a90a3c78 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. f8b1ea3a-d62e-e00d-e053-6394a90a5689 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50 ZINC OXIDE Babo Botanicals, Inc. f8b272f6-8726-de1d-e053-6294a90a7b1e 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Sport Sunscreen SPF 50 ZINC OXIDE Babo Botanicals, Inc. e3ca7840-4882-d605-e053-2a95a90af6ab 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow MINERAL SUNSCREEN Babo Botanicals, Inc. ab39d9f0-d869-6f33-e053-2995a90a08d4 2024-12-12 Warnings Exact identifier application number: M020 Alumier MD Sheer Hydration TITANIUM DIOXIDE, ZINC OXIDE Alumier Labs 88dedeb8-963f-5849-e053-2995a90aab72 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Extra Light Tint ZINC OXIDE MV Advanced 7834c649-5f6d-b005-e053-2a91aa0a1084 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Light Tint ZINC OXIDE MV Advanced 783649af-d746-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Medium Tint ZINC OXIDE MV Advanced 783649af-d768-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Babo SPF 30 Clear Zinc Fragrance Free Sport MINERAL SUNSCREEN Babo Botanicals, Inc. b1a9f76d-0cef-29da-e053-2995a90af34c 2024-12-12 Warnings Exact identifier application number: M020 Babo Baby Face Mineral Sunscreen MINERAL SUNSCREEN Babo Botanicals, Inc. b131664d-1ad2-0a2f-e053-2995a90acbda 2024-12-12 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