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#
Contacts and useful links#
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
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 16a2c1cd-ae95-d910-f03d-7e06b11dd243 | Product name | 5 | 20260202 |
| 653485de-0601-41e4-82db-7a60bb223e27 | Product name | 1 | 20251024 |
| 23fb3cda-2b50-f3d3-ebde-f542350bd77b | Product name | 4 | 20240828 |
| 081b54f0-4545-48b6-b854-03e1401f09ea | Product name | 1 | 20230112 |
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| aead65a2-216e-4ff8-a178-44aab77c24ed | Product name | 1 | 20180531 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66171-123-01 | Dr.Denese SPF 30 Defense Day | 120 g in 1 TUBE | CREAM | 120 | 7 | |
| 66171-123-02 | Dr.Denese SPF 30 Defense Day | 45 g in 1 TUBE | CREAM | 45 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .BETA.-SITOSTEROL | INACTIVE INGREDIENT | S347WMO6M4 | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL BEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | 1 | |
| IMIDUREA | INACTIVE INGREDIENT | M629807ATL | 1 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| NIACIN | INACTIVE INGREDIENT | 2679MF687A | 1 | |
| OCTYLDODECYL NEOPENTANOATE | INACTIVE INGREDIENT | X8725R883T | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PHYTONADIONE | INACTIVE INGREDIENT | A034SE7857 | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| THIAMINE MONONITRATE | INACTIVE INGREDIENT | 8K0I04919X | 1 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr.Denese SPF 30 Defense Day
- ZINC OXIDE, OCTINOXATE
- SILICON DIOXIDE
- GLYCERIN
- ISODODECANE
- PROPYLENE GLYCOL
- IMIDUREA
- PHENOXYETHANOL
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- FERROSOFERRIC OXIDE
- CYCLOMETHICONE
- WATER
- DIMETHICONE
- GLYCERYL DIBEHENATE
- ALKYL (C12-15) BENZOATE
- ALOE VERA LEAF
- TALC
- OCTYLDODECYL NEOPENTANOATE
- BUTYLENE GLYCOL
- PHYTONADIONE
- VITAMIN A PALMITATE
- ASCORBIC ACID
- ASCORBYL PALMITATE
- ZINC OXIDE
- OCTINOXATE
- .BETA.-SITOSTEROL
- NIACIN
- THIAMINE MONONITRATE
- POLYSORBATE 80
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66171-123 | 66171-123-01, 66171-123-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | GEL / TOPICAL | 7 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 10 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, DELAYED RELEASE / ORAL | 75 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | POWDER, FOR SUSPENSION / ORAL | 0.08 mg | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / TOPICAL | 20 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | CAPSULE, DELAYED RELEASE / ORAL | 31 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CREAM / TOPICAL | 0.02 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| IMIDUREA | IMIDUREA | M629807ATL | CREAM / TOPICAL | 0.4 %w/w | ||
| IMIDUREA | IMIDUREA | M629807ATL | CREAM / TOPICAL | 0.4 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | SOLUTION / ORAL | 3 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | POWDER, FOR SUSPENSION / ORAL | 0.08 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / TOPICAL | 0.04 %w/w | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | CAPSULE / ORAL | 51 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CREAM / TOPICAL | 0.02 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| GLYCERYL BEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | POWDER, FOR SUSPENSION / ORAL | 0.08 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dr.Denese SPF 30 Defense Day | ZINC OXIDE, OCTINOXATE | SkinScience Labs, Inc | 511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa | 2023-12-12 | Warnings | 66171-123-01 66171-123-02 66171-123 66171012302 66171012301 0c5b74ab-a033-2667-e063-6294a90a757e 511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

