Indications and uses
Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Dark Spot Sun Defense
- Manufacturer
- Dr. Dennis Gross Skincare™, LLC | PhytogenX
- Effective date
- 2024-05-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:03:15
Label at a glance#
ProductDark Spot Sun Defense Broad Spectrum SPF 50
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure Children under 6 months: ask a doctor Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures includi...
Storage and handling
Protect the product in this container from excessive heat and direct sun
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients | Purpose |
|---|---|
| Titanium Dioxide 4.9% | Sunscreen |
| Zinc Oxide 4.42% | Sunscreen |
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure
- Children under 6 months: ask a doctor
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
Other information
- Protect the product in this container from excessive heat and direct sun
Inactive ingredients
Acrylates/Carbamate Copolymer, Aluminum Hydroxide, Ascorbyl Glucoside, Benzyl Alcohol, BHT, Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate, Boerhavia Diffusa Root Extract, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Carbomer, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Citrus Aurantium Dulcis (Orange) Peel Extract, Coco-Caprylate/- Caprate, Coconut Alkanes, Disodium EDTA, Echium Plantagineum Seed Oil, Glycerin, Glycolic Acid, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Cyclodextrin, Isohexadecane, Isononyl Isononanoate, Isopropyl Titanium Triisostearate, Magnesium Ascorbyl Phosphate, Melatonin, Nordihydroguaiaretic Acid Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (Olive) Fruit Oil, Oleanolic Acid, Oryza Sativa (Rice) Extract, Palmitoyl Tripeptide-38, PEG-60 Almond Glycerides, Pentylene Glycol, Phenoxyethanol, Phospholipids, Polyhydroxystearic Acid, Polysorbate 60, Potassium Sorbate, Propanediol, Saccharide Isomerate, Sodium Benzoate, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Sphingolipids, Stearic Acid, Tetrahexyldecyl Ascorbate, Tocopherol, Water/Aqua/ Eau, Xanthan Gum, Zinc PCA
Questions?
Call 1-888-830-7546 Monday through Friday, 9:00 AM to 5:00 PM EST
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
FOR FACE & EYES
Dr Dennis Gross
NO
CHEMICAL
FILTERS
SKINCARE
dark spot
sun defense
Broad Spectrum
SPF 50 Sunscreen
1.7 fl oz/50ml e
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58633-315-10 | 2024-05-08 | C162847 | 48780-1 | 9d75b9d0-c910-f424-e053-dadaa90a57ce | Dark Spot Sun Defense Broad Spectrum SPF 50 |
| 58633-315-60 | 2024-05-08 | C162847 | 48780-1 | 9d75b9d0-c910-f424-e053-dadaa90a57ce | Dark Spot Sun Defense Broad Spectrum SPF 50 |
| 58633-315-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c910-f424-e053-dadaa90a57ce | Dark Spot Sun Defense Broad Spectrum SPF 50 |
| 58633-315-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c910-f424-e053-dadaa90a57ce | Dark Spot Sun Defense Broad Spectrum SPF 50 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER | INACTIVE INGREDIENT | R0R8I3X29J | 1 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| Aluminum Hydroxide | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| Ascorbyl Glucoside | INACTIVE INGREDIENT | 2V52R0NHXW | 1 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate | INACTIVE INGREDIENT | 7D4Q5YJ8NV | 1 | |
| Boerhavia Diffusa Root | INACTIVE INGREDIENT | KR0SR09KYL | 1 | |
| Butylated Hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| Coco-Caprylate/Caprate | INACTIVE INGREDIENT | 8D9H4QU99H | 1 | |
| Coconut Alkanes | INACTIVE INGREDIENT | 1E5KJY107T | 1 | |
| Echium Plantagineum Seed Oil | INACTIVE INGREDIENT | PIB7XBU8XW | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Evening Primrose Oil | INACTIVE INGREDIENT | 3Q9L08K71N | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Glycolic Acid | INACTIVE INGREDIENT | 0WT12SX38S | 1 | |
| Hyaluronate Sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| Hydrogenated Soybean Lecithin | INACTIVE INGREDIENT | H1109Z9J4N | 1 | |
| Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%) | INACTIVE INGREDIENT | 86FQE96TZ4 | 1 | |
| Hydroxypropyl .Beta.-Cyclodextrin | INACTIVE INGREDIENT | 1I96OHX6EK | 1 | |
| Isohexadecane | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| Isononyl Isononanoate | INACTIVE INGREDIENT | S4V5BS6GCX | 1 | |
| Isopropyl Titanium Triisostearate | INACTIVE INGREDIENT | 949E3KBJ1I | 1 | |
| Lecithin, Soybean | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| Magnesium Ascorbyl Phosphate | INACTIVE INGREDIENT | 0R822556M5 | 1 | |
| Masoprocol | INACTIVE INGREDIENT | 7BO8G1BYQU | 1 | |
| Melatonin | INACTIVE INGREDIENT | JL5DK93RCL | 1 | |
| Oleanolic Acid | INACTIVE INGREDIENT | 6SMK8R7TGJ | 1 | |
| Olive Oil | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| Orange Oil | INACTIVE INGREDIENT | AKN3KSD11B | 1 | |
| Orange Peel | INACTIVE INGREDIENT | TI9T76XD44 | 1 | |
| Palmitoyl Lysyldioxymethionyllysine | INACTIVE INGREDIENT | T7A529FB8O | 1 | |
| PEG-60 Almond Glycerides | INACTIVE INGREDIENT | 4Y0E651N0F | 1 | |
| Pentylene Glycol | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Polyhydroxystearic Acid (2300 MW) | INACTIVE INGREDIENT | YXH47AOU0F | 1 | |
| Polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| Potassium Sorbate | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| Propanediol | INACTIVE INGREDIENT | 5965N8W85T | 1 | |
| Rice Germ | INACTIVE INGREDIENT | 7N2B70SFEZ | 1 | |
| Saccharide Isomerate | INACTIVE INGREDIENT | W8K377W98I | 1 | |
| Safflower Oil | INACTIVE INGREDIENT | 65UEH262IS | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| Sodium Pyrrolidone Carboxylate | INACTIVE INGREDIENT | 469OTG57A2 | 1 | |
| SOY SPHINGOLIPIDS | INACTIVE INGREDIENT | P491F5HP1U | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Tetrahexyldecyl Ascorbate | INACTIVE INGREDIENT | 9LBV3F07AZ | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 | |
| Zinc Pidolate | INACTIVE INGREDIENT | C32PQ86DH4 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dark Spot Sun Defense Broad Spectrum SPF 50
- Titanium Dioxide and Zinc Oxide
- Titanium Dioxide
- Zinc Oxide
- Water
- Glycerin
- Butylene Glycol
- Pentylene Glycol
- Isononyl Isononanoate
- Safflower Oil
- Olive Oil
- Coconut Alkanes
- Alkyl (C12-15) Benzoate
- Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%)
- Melatonin
- Ascorbyl Glucoside
- Magnesium Ascorbyl Phosphate
- Tetrahexyldecyl Ascorbate
- Boerhavia Diffusa Root
- Echium Plantagineum Seed Oil
- Rice Germ
- Tocopherol
- Saccharide Isomerate
- Orange Peel
- Evening Primrose Oil
- Oleanolic Acid
- Palmitoyl Lysyldioxymethionyllysine
- Lecithin, Soybean
- Hyaluronate Sodium
- SOY SPHINGOLIPIDS
- Glycolic Acid
- Sodium Pyrrolidone Carboxylate
- Zinc Pidolate
- Hydrogenated Soybean Lecithin
- ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER
- Coco-Caprylate/Caprate
- Isohexadecane
- Caprylyl Glycol
- Masoprocol
- Aluminum Hydroxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58633-315 | 58633-315-10, 58633-315-60 |
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 |
|---|---|---|---|---|---|---|
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| Hydroxypropyl .Beta.-Cyclodextrin | HYDROXYPROPYL BETADEX | 1I96OHX6EK | TABLET / ORAL | 600 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| Aluminum Hydroxide | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | OINTMENT / TOPICAL | NA | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| Olive Oil | OLIVE OIL | 6UYK2W1W1E | SOLUTION / ORAL | 425 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| Sodium Pyrrolidone Carboxylate | SODIUM PYRROLIDONE CARBOXYLATE | 469OTG57A2 | LOTION / TOPICAL | 42 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / RECTAL | 129 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / TOPICAL | 2.85 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, COATED / ORAL | NA | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | LOTION / TOPICAL | 5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| Orange Oil | ORANGE OIL, COLD PRESSED | AKN3KSD11B | SUSPENSION / ORAL | 1 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / SUBLINGUAL | 0.13 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRAVITREAL | 23 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRA-ARTICULAR | 0.05 %w/v | ||
| Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w |
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 |
|---|---|---|---|---|---|---|
| 27ddcf7f-24e1-48f9-bda4-2afaf059851d | 986bfc6d-fe2f-4604-8637-778298807f87 | 2024-05-07 | Warnings | 27ddcf7f-24e1-48f9-bda4-2afaf059851d 986bfc6d-fe2f-4604-8637-778298807f87 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.