Home NDC 67510-0082 Kids Sunscreen
Product NDC 67510-0082
11-digit product format 675100082
Labeler code 67510
Product ID 67510-0082_941eed90-3843-24f5-e053-2995a90aa553
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate and Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Kareway Product, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-12-01
Marketing end 0000-00-00
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 7 g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 1 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67510-0082-5 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67510-0082-5 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67510-0082-5 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67510-0082-5 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67510-0082-5 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67510-0082-5 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67510-0082-5 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67510-0082-5 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67510-0082-5 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 67510-0082-5 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 67510-0082-5 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67510-0082-5 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67510-0082-5 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67510-0082-5 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67510-0082-5 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 67510-0082-5 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 67510-0082-5 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 67510-0082-5 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 67510-0082-5 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67510-0082-5 Kids Sunscreen 100 mL in 1 TUBE LOTION 100 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67510-0082 KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.] 5 Legacy NDC, 1 package rows 20191005_6d99a7c2-7c49-410f-9c36-fe83213c8a76.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 67510-0082-5 67510008205 100 mL in 1 TUBE 100 ml Historical