Home NDC 42421-926 Safe Harbor - Natural - Sensitive SPF50 Broad Spectrum
Product NDC 42421-926
11-digit product format 424210926
Labeler code 42421
Product ID 42421-926_e615176c-e829-4f5c-8d46-0fb405e9c1e2
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Emilia Personal Care Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-01-05
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 10 g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 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 42421-926-11 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 42421-926-11 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 42421-926-11 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42421-926-11 Safe Harbor - Natural - Sensitive SPF50 Broad Spectrum 118.3 mL in 1 TUBE LOTION 118.3 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 ASPALATHUS LINEARIS LEAF INACTIVE INGREDIENT H7UGK1GJCU SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 CETYL DIMETHICONE 150 INACTIVE INGREDIENT 5L694Y0T22 SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) INACTIVE INGREDIENT V2W71V8T0X SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 CHAMOMILE INACTIVE INGREDIENT FGL3685T2X SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 HIPPOPHAE RHAMNOIDES FRUIT OIL INACTIVE INGREDIENT TA4JCF9S1J SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 LEVOMENOL INACTIVE INGREDIENT 24WE03BX2T SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 MELISSA OFFICINALIS LEAF INACTIVE INGREDIENT 50D2ZE9219 SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 MICROCRYSTALLINE WAX INACTIVE INGREDIENT XOF597Q3KY SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 PORPHYRA UMBILICALIS INACTIVE INGREDIENT 14AN0J70WO SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 SODIUM LACTATE INACTIVE INGREDIENT TU7HW0W0QT SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 SOY ISOFLAVONES INACTIVE INGREDIENT 71B37NR06D SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 TILIA X EUROPAEA FLOWER INACTIVE INGREDIENT NHV2K1OUDH SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 TRICAPRYLIN INACTIVE INGREDIENT 6P92858988 SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 TRIMETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT FZ07E4LW2M SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42421-926 SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.] 1 Legacy NDC, 1 package rows 20140105_e615176c-e829-4f5c-8d46-0fb405e9c1e2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 42421-926-11 42421092611 118.3 mL in 1 TUBE 118.3 ml Historical