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
ZINC OXIDE; OCTINOXATE
Active strength
7.5; 7.5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
ZINC OXIDE7.5 g/100g
OCTINOXATE7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
511dd97b-0f83-4ce9-8bfd-fa385f0dc8aaAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
application number: M020

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