Dr.Denese SPF 30 Defense Day Cream

Manufacturer
SkinScience Labs, Inc | Englewood Lab, Inc.
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:04:44

Label at a glance#

ProductDr.Denese SPF 30 Defense Day
Active ingredientZINC OXIDE, OCTINOXATE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                     Purpose Zinc Oxide 7.5%                                                   Sunscreen Octinoxate 7.5% (Ethyl Hexyl Methoxycinnamate)   Sunscreen

OTC - PURPOSE SECTION

Uses  - Helps prevent sunburn  - Higher SPF provides more protection.

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Higher SPF gives more sun protection.

WARNINGS SECTION

Warnings  For external use only

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

- If redness and irritation develops and persists discontinue use and consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

In case of accidental ingestion seek medical assistance or contact Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions  - Apply liberally to sun exposed areas 30 minutes before sun exposure or as needed.  - Children under 6 months : Consult physician. - Reapply as needed. Reapply before extended sun exposure, after swimming, towel drying, or sweating.

PRECAUTIONS SECTION

Other information  - Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients Cyclomethicone, Aqua (Water), Dimethicone, Polysilicone II, Glyceryl Behenate, C12-15 Alkyl Benzoate, Aloe Barbadensis Leaf Extract, Talc, Butyl Methoxydibenzolmethane, Octyldodecyl Neopentanoate, DEA Oleth-3 Phosphate, Cetyl Dimethicone Copolyol, PEG/PPG-18/18 Dimethicone, Melanine, Hydrogenated Lecithin, Butylene Glycol, Phytonadione (Vit K), Retinyl Palmitate (Vit A), Tocopheryl Acetate (Vit E), Ascorbic Acid, Ascorbyl Palmitate (Vit C), Beta Sitosterol, Niacin (Vit B3), Calcium Panthotenate (Vit B 5), Pyridoxine HCI (Vit B 6), Thiamine Nitrate (Vit B 1), Polysorbate 80, Nylon 12, Silica, Polyglyceryl-6 Octa Stearte, Glycerin, Isododecane, Propylene Glycol, Imidazolidinyl Urea, Phenoxyethanol May Contain: Iron Oxides ( CI 77491, CI 77492, CI 77499).


DESCRIPTION SECTION

Made in USA  SkinScience Labs Inc.  Ridgefield, NJ 07657  www.drdenese.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR. DENESE NEW YORK  SPF 30 Defense Day Cream  Broad Spectrum UVA/UVB - Matte Finish  Tinted - Oil Free Zinc-Oxide Based  4 oz (120 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts  Made in USA  SkinScience Labs Inc.  Ridgefield, NJ 07657  www.drdenese.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Denese ADr Denese A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Denese BDr Denese B

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.BETA.-SITOSTEROLINACTIVE INGREDIENTS347WMO6M41
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS21
IMIDUREAINACTIVE INGREDIENTM629807ATL1
ISODODECANEINACTIVE INGREDIENTA8289P68Y21
NIACININACTIVE INGREDIENT2679MF687A1
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883T1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHYTONADIONEINACTIVE INGREDIENTA034SE78571
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TALCINACTIVE INGREDIENT7SEV7J4R1U1
THIAMINE MONONITRATEINACTIVE INGREDIENT8K0I04919X1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66171-12366171-123-01, 66171-123-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 174 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii+route
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
60 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / BUCCAL1 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
60 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2TABLET, FILM COATED, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2TABLET, DELAYED RELEASE / ORAL75 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
60 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
60 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2POWDER, FOR SUSPENSION / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2CAPSULE, DELAYED RELEASE / ORAL31 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2TABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
39 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
60 equally ranked IID candidates
IMIDUREAIMIDUREAM629807ATLCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
IMIDUREAIMIDUREAM629807ATLCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2SOLUTION / ORAL3 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
30 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
6 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2POWDER, FOR SUSPENSION / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2CAPSULE / ORAL51 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii candidate
30 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
60 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2TABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
60 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
60 equally ranked IID candidates
GLYCERYL BEHENATEGLYCERYL DIBEHENATER8WTH25YS2POWDER, FOR SUSPENSION / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
30 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
60 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Denese SPF 30 Defense DayZINC OXIDE, OCTINOXATESkinScience Labs, Inc511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa2023-12-12WarningsExact identifier
ndc (package): 66171-123-01
ndc (package): 66171-123-02
ndc (product): 66171-123
ndc11 (package): 66171012302
ndc11 (package): 66171012301
spl id: 0c5b74ab-a033-2667-e063-6294a90a757e
spl set id: 511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa

Reported adverse events (FAERS/openFDA)#

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