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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42421-926-112020-01-31C16284748780-19d75b9d0-e140-f424-e053-dadaa90a57ceSafe Harbor Natural Suncare

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42421-926-11Safe Harbor - Natural - Sensitive SPF50 Broad Spectrum118.3 mL in 1 TUBELOTION118.31

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
ASPALATHUS LINEARIS LEAFINACTIVE INGREDIENTH7UGK1GJCUSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
CETYL DIMETHICONE 150INACTIVE INGREDIENT5L694Y0T22SAFE 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 INGREDIENTV2W71V8T0XSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
HIPPOPHAE RHAMNOIDES FRUIT OILINACTIVE INGREDIENTTA4JCF9S1JSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
PORPHYRA UMBILICALISINACTIVE INGREDIENT14AN0J70WOSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
SOY ISOFLAVONESINACTIVE INGREDIENT71B37NR06DSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
TILIA X EUROPAEA FLOWERINACTIVE INGREDIENTNHV2K1OUDHSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
TRICAPRYLININACTIVE INGREDIENT6P92858988SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
TRIMETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTFZ07E4LW2MSAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSAFE 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
NDCDashboard titleSPL versionValidationDashboard ZIP
42421-926SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1Legacy NDC, 1 package rows20140105_e615176c-e829-4f5c-8d46-0fb405e9c1e2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42421-926-1142421092611118.3 mL in 1 TUBE118.3 mlHistorical