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 257 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLE CCC Neutral Medium Light TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. 615f5e39-695d-41d4-af59-e0d3b76789bb 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Warm Deep TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE KW ABSC, INC. 6ab3e360-8104-4439-93fb-e11bc4a77558 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Neutral Medium TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. a297ff64-678c-4936-8384-022606a2f33c 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Neutral Fair TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Cool Medium Deep TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. 2e0365f9-d3c6-4404-90ac-772a829b3ade 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEG OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abae8f-53db-b592-e063-6294a90adabb 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29aba80c-55b7-b8d9-e063-6294a90a5cc1 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abe97b-e9b3-6e27-e063-6294a90ae3ed 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDEN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abdf3c-fb54-a5e3-e063-6394a90af450 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR ZINC OXIDE COSMAX USA, CORPORATION 29ac756b-3df7-50c9-e063-6394a90aa479 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM RICH ZINC OXIDE COSMAX USA, CORPORATION 29ac51a0-07e7-ad7b-e063-6294a90ae777 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM DEEPEST ZINC OXIDE COSMAX USA, CORPORATION 29ad12e2-0a2e-7138-e063-6394a90aebaf 2024-12-19 Warnings Exact identifier application number: M020 CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products, Inc. f2e34230-7bfb-455f-8b33-6bff96fd9f0a 2024-12-19 Warnings Exact identifier application number: M020 Anew Platinum DayCream Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE COSMAX USA, CORPORATION 56200212-bedc-6e1e-e063-6394a90a3666 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29868d60-b900-e0ad-e063-6294a90af87a 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM ZINC OXIDE COSMAX USA, CORPORATION 298707d4-72ed-796f-e063-6294a90aa5cd 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT ZINC OXIDE COSMAX USA, CORPORATION 29871c02-9adf-6266-e063-6394a90a20ab 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM TAN ZINC OXIDE COSMAX USA, CORPORATION 29874029-24bf-b2ce-e063-6394a90acd4d 2024-12-18 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. 2990e4ff-5bdb-3008-e063-6294a90a9497 2024-12-18 Warnings Exact identifier application number: M020 Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29915354-4673-7444-e063-6294a90a0fd1 2024-12-18 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