FDA.reportPublic FDA data

Dr.Denese SPF 30 Defense Day

Product NDC
66171-123
11-digit product format
661710123
Labeler code
66171
Product ID
66171-123_0c5b74ab-a033-2667-e063-6294a90a757e
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTINOXATE
Dosage form
CREAM
Route
TOPICAL
Labeler
SkinScience Labs, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-21
Substance
OCTINOXATE; ZINC OXIDE
Active strength
7.5; 7.5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dr.Denese SPF 30 Defense Day
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100g
ZINC OXIDE7.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66171-123-01Dr.Denese SPF 30 Defense Day120 g in 1 TUBECREAM1207
66171-123-02Dr.Denese SPF 30 Defense Day45 g in 1 TUBECREAM457

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
.BETA.-SITOSTEROLINACTIVE INGREDIENTS347WMO6M4DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RADR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
IMIDUREAINACTIVE INGREDIENTM629807ATLDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
NIACININACTIVE INGREDIENT2679MF687ADR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883TDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
PHYTONADIONEINACTIVE INGREDIENTA034SE7857DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
THIAMINE MONONITRATEINACTIVE INGREDIENT8K0I04919XDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66171-123DR.DENESE SPF 30 DEFENSE DAY (ZINC OXIDE, OCTINOXATE) CREAM [SKINSCIENCE LABS, INC]7Current NDC, Legacy NDC, 2 package rows20231217_511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66171-123-0166171012301120 g in 1 TUBE (66171-123-01) 120 g2017-12-190000-00-00NoNoCurrent
66171-123-026617101230245 g in 1 TUBE (66171-123-02) 45 g2017-12-190000-00-00NoNoCurrent