Home NDC 42421-875 Safe Harbor Natural Suncare
Product NDC 42421-875
11-digit product format 424210875
Labeler code 42421
Product ID 42421-875_cff907f1-e5d0-80bc-e053-2a95a90ae38a
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 2015-11-15
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 9 g/124g; g/124g
NDC exclude flag No
Listing certified through 2022-12-31
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42421-875-15 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42421-875-15 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42421-875-15 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42421-875-15 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42421-875-15 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42421-875-15 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42421-875-15 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42421-875-15 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42421-875-15 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42421-875-15 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42421-875-15 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42421-875-15 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 42421-875-15 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 42421-875-15 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 ASPALATHUS LINEARIS LEAF INACTIVE INGREDIENT H7UGK1GJCU SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 CETEARYL GLUCOSIDE INACTIVE INGREDIENT 09FUA47KNA SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 ECHINACEA PURPUREA ROOT INACTIVE INGREDIENT OS64WTR4KU SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 GLYCERYL 1-STEARATE INACTIVE INGREDIENT 258491E1RZ SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 HIPPOPHAE RHAMNOIDES SEED OIL INACTIVE INGREDIENT T53SBG6741 SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 LEVOMENOL INACTIVE INGREDIENT 24WE03BX2T SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 MATRICARIA RECUTITA ROOT INACTIVE INGREDIENT BTG5H50X7F SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 MELISSA OFFICINALIS LEAF INACTIVE INGREDIENT 50D2ZE9219 SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 OAT INACTIVE INGREDIENT Z6J799EAJK SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 PEG-40 STEARATE INACTIVE INGREDIENT ECU18C66Q7 SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 PORPHYRA UMBILICALIS INACTIVE INGREDIENT 14AN0J70WO SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 SESAME OIL INACTIVE INGREDIENT QX10HYY4QV SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 SODIUM LACTATE INACTIVE INGREDIENT TU7HW0W0QT SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 TILIA X EUROPAEA FLOWER INACTIVE INGREDIENT NHV2K1OUDH SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 TRIMETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT FZ07E4LW2M SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42421-875-15 42421087515 124 g in 1 TUBE (42421-875-15) 124 g 2015-11-15 0000-00-00 No No Current