FDA.reportPublic FDA data

Harmon Revitalizing Facial Smoother Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Sunscreen

Product NDC
63940-472
11-digit product format
639400472
Labeler code
63940
Product ID
63940-472_653c1abf-a2e4-4d71-903d-bd16c1625b29
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Harmon Stores Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63940-472-122020-01-31C16284748780-19d75b9d0-4f51-f424-e053-dadaa90a57ceHarmon Revitalizing Facial Smoother Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63940-472-12Harmon Revitalizing Facial Smoother Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Sunscreen35 mL in 1 TUBECREAM351
63940-472-12Harmon Revitalizing Facial Smoother Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Sunscreen1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
C30-45 ALKYL METHICONEINACTIVE INGREDIENTNFX970DSI2HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
CETYL DIMETHICONE 45INACTIVE INGREDIENTIK315POC44HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OKHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VHARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-472HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [HARMON STORES INC.]1Legacy NDC, 2 package rows20140423_653c1abf-a2e4-4d71-903d-bd16c1625b29.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63940-472-126394004721235 mL in 1 TUBE35 mlHistorical