FDA.reportPublic FDA data

Safe Harbor Natural Suncare

Product NDC
42421-575
11-digit product format
424210575
Labeler code
42421
Product ID
42421-575_457b8d97-15ee-44eb-a985-b6e69e1ad1d3
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42421-575IInactivated by FDA2026-07-31
excluded packagepackage42421-57542421-575-15IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YMLABSSPF15 FLAVORED LIP BALMYusef Manufacturing Laboratories6c456df1-db54-481b-b583-186b9bdaf6702026-01-12WarningsExact identifier
OI LIN SUNMILK SUNSCREEN SPF 30SUNSCREEN, TITANIUM DIOXIDESunrider Manufacturing L.P.26b57314-1616-4ca4-b65f-a363c525b4322025-12-29WarningsExact identifier
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDEEthoSun, Incd7d2bca6-5000-4cb9-b004-b1ae286f60352025-06-03WarningsExact identifier
Scar Cream SPF 30AVOBENZONE, OCTOCRYLENE, OXYBENZONEGenomma Lab827d4e72-4bb7-2ec7-e053-2991aa0a983e2019-02-22WarningsExact identifier
Advanced Anti-Wrinkle Therapy CicatricureAVOBENXONE 3%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 4%Genomma Lab8153c706-d1bd-6c42-e053-2991aa0afda42019-02-18WarningsExact identifier
ALL WEATHER SPF 15 LIP BALMZINC OXIDEBurt's Bees604f0949-6d6d-b3ea-e053-2a91aa0acc452018-12-17WarningsExact identifier
CLE CCC Golden Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b7a4847f-b84d-4f36-8787-104eccd838a02018-12-03WarningsExact identifier
CLE CCC Warm Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.229c20a3-6288-4ac3-9098-6d1622e906ab2018-11-29WarningsExact identifier
CLE CCC Warm Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.fc90fb8a-44b3-47cd-882e-94ed324ed3892018-11-27WarningsExact identifier
CLE CCC Warm MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b585f216-4234-47c5-9a6b-8b133ef48aae2018-11-27WarningsExact identifier
CLE CCC Warm LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.14891e26-b3b6-4545-99b1-da914b7f56292018-11-24WarningsExact identifier
Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 MinGLOSSIER SUN GLAZE GLEAMING SUNSCREEN OIL BROAD SPECTRUM SPF 30 WATER RESISTANT 40 MINGlossier Inc.35e70dcf-a00a-4401-8127-09219931e3ac2018-11-13WarningsExact identifier
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20Mana Products657d5090-30a8-46d0-879d-469178aa234d2018-01-25WarningsExact identifier
Everyday Sheer Coverage Medium Tint SPF 20ZINC OXIDEAllure Labs Inc89bdf852-9420-4736-b50d-0af55afb6bd32017-12-20WarningsExact identifier
Everyday Sheer Coverage Light Tint SPF 20ZINC OXIDEAllure Labs Incc70a3f80-84a9-4ce7-88a1-4c50d15d758c2017-12-15WarningsExact identifier
Mineral Sunscreen Moisturizer Broad Spectrum SPF 20ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc316c2132-ab81-47f6-8e80-71e9252a26632017-12-12WarningsExact identifier
Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inca149b716-58f5-4da1-b330-f79fa7596c182017-12-12WarningsExact identifier
Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc96d2d0f1-dbde-4b66-9b2c-9d07f75470662017-12-11WarningsExact identifier
Pyratine XR Creme With Sunscreen Broad Spectrum SPF30ZINC OXIDEAllure Labs Incfc316b19-c1cf-4b5b-9f22-9672b7d0cbff2017-12-07WarningsExact identifier
Cover Recover SPF 30 IvoryZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incfe207b88-8eb8-424d-89b4-8d5b188dd2c32017-12-05WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings : For external use only. When using this product: • Keep out of eyes • Rinse with water to remove • Stop use and ask a doctor if rash or irritation develops and lasts.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42421-575-152020-01-31C16284748780-19d75b9d0-535f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42421-575-15Safe Harbor Natural SuncareBroad Spectrum124 g in 1 TUBELOTION1241

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
ALLANTOININACTIVE INGREDIENT344S277G0ZSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
ASPALATHUS LINEARIS LEAFINACTIVE INGREDIENTH7UGK1GJCUSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNASAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
ECHINACEA PURPUREA ROOTINACTIVE INGREDIENTOS64WTR4KUSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
HIPPOPHAE RHAMNOIDES SEED OILINACTIVE INGREDIENTT53SBG6741SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
MATRICARIA RECUTITA ROOTINACTIVE INGREDIENTBTG5H50X7FSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
OATINACTIVE INGREDIENTZ6J799EAJKSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
SESAME OILINACTIVE INGREDIENTQX10HYY4QVSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
TILIA X EUROPAEA FLOWERINACTIVE INGREDIENTNHV2K1OUDHSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
TRIMETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTFZ07E4LW2MSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
WATERINACTIVE INGREDIENT059QF0KO0RSAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42421-575SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]1Legacy NDC, 1 package rows20151121_ae98d652-b2c8-4c81-a126-e054d6b8eb88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42421-575-1542421057515124 g in 1 TUBE124 gHistorical