FDA.reportPublic FDA data

mally Face Defender Foundation

Product NDC
76119-1328
11-digit product format
761191328
Labeler code
76119
Product ID
76119-1328_9e518ddf-9ed6-49e0-94dd-d22e96f3c97f
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
MallyGirl, LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-29
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
2 mL/53.2mL; mL/53.2mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76119-1328-12020-01-31C16284748780-19d75b9d0-1405-f424-e053-dadaa90a57cemally Face Defender - Tan Foundation Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76119-1328-1mally Face Defender Foundation1 in 1 BOXCREAM11
76119-1328-1mally Face Defender Foundation59.2 mL in 1 TUBECREAM59.21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)INACTIVE INGREDIENTV2W71V8T0XMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
LYSINEINACTIVE INGREDIENTK3Z4F929H6MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
MICAINACTIVE INGREDIENTV8A1AW0880MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
NYLON-12INACTIVE INGREDIENT446U8J075BMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883TMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
PHYTANTRIOLINACTIVE INGREDIENT8LVI07A72WMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
POLYETHYLENE GLYCOL 900INACTIVE INGREDIENTUEP843BRCQMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971GMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BMALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76119-1328MALLY FACE DEFENDER FOUNDATION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]1Legacy NDC, 2 package rows20120419_412f5c63-9466-429c-84e9-b7dedfc1f3fe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76119-1328-1761191328011 in 1 BOXHistorical