FDA.reportPublic FDA data

Protector

Product NDC
42248-127
11-digit product format
422480127
Labeler code
42248
Product ID
42248-127_c1540d77-5935-458f-b238-50e2e49b57cf
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Zenith Medicosm SL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE
Active strength
4 mL/50mL; mL/50mL; mL/50mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42248-127-022019-11-13C16284748780-197449f38-b97e-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42248-127-02ProtectorR Plus1 in 1 BOXCREAM12
42248-127-02ProtectorR Plus50 mL in 1 TUBECREAM502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
(2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANEINACTIVE INGREDIENTN28HAC3H5PPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAIPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
COLLAGEN, SOLUBLE, FISH SKININACTIVE INGREDIENT8JC99XGU4WPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
ETHYLPARABENINACTIVE INGREDIENT14255EXE39PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WTPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
HYDROXYPROLINEINACTIVE INGREDIENTRMB44WO89XPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
IMIDUREAINACTIVE INGREDIENTM629807ATLPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
WATERINACTIVE INGREDIENT059QF0KO0RPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42248-127PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]2Legacy NDC, 2 package rows20120222_72ac1954-f94e-494c-99cd-3c70a321e45f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42248-127-02422480127021 in 1 BOXHistorical