FDA.reportPublic FDA data

No7 Restore and Renew Day Sunscreen

Product NDC
11489-078
11-digit product format
114890078
Labeler code
11489
Product ID
11489-078_b4aa84e3-5ad6-44a4-83ed-f9784a63c608
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
BCM Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-12-10
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2 g/50g; g/50g; g/50g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11489-078-012020-01-31C16284748780-19d75b9d0-9409-f424-e053-dadaa90a57ceNo7 Restore and Renew Day Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-078-01No7 Restore and Renew Day Sunscreen1 in 1 CARTONCREAM11
11489-078-01No7 Restore and Renew Day Sunscreen50 g in 1 JARCREAM501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTISALATEACTIVE MOIETY4X49Y0596WNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ASCORBYL GLUCOSIDEINACTIVE INGREDIENT2V52R0NHXWNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RANO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CERAMIDE 1INACTIVE INGREDIENT5THT33P7X7NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CERAMIDE 3INACTIVE INGREDIENT4370DF050BNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CERAMIDE 6 IIINACTIVE INGREDIENTF1X8L2B00JNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BANO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785INO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ISOSTEARYL ISOSTEARATEINACTIVE INGREDIENTIV0Z586Z4YNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PHYTOSPHINGOSINEINACTIVE INGREDIENTGIN46U9Q2QNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ROSA MOSCHATA SEED OILINACTIVE INGREDIENTT031ZE559TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFONO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-078NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1Legacy NDC, 2 package rows20121220_744c8142-83c6-4398-a7ca-22c781f4bf6e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11489-078-01114890078011 in 1 CARTONHistorical