DARK SPOT SUN DEFENSE  BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide cream 
Dr. Dennis Gross Skincare™, LLC

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Dark Spot Sun Defense
Broad Spectrum SPF 50

Drug Facts

Active IngredientsPurpose
Titanium Dioxide 4.9%Sunscreen
Zinc Oxide 4.42%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
DARK SPOT SUN DEFENSE   BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58633-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide49 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide44.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Pentylene Glycol (UNII: 50C1307PZG)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Safflower Oil (UNII: 65UEH262IS)  
Olive Oil (UNII: 6UYK2W1W1E)  
Coconut Alkanes (UNII: 1E5KJY107T)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
Melatonin (UNII: JL5DK93RCL)  
Ascorbyl Glucoside (UNII: 2V52R0NHXW)  
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
Echium Plantagineum Seed Oil (UNII: PIB7XBU8XW)  
Rice Germ (UNII: 7N2B70SFEZ)  
Tocopherol (UNII: R0ZB2556P8)  
Saccharide Isomerate (UNII: W8K377W98I)  
Orange Peel (UNII: TI9T76XD44)  
Evening Primrose Oil (UNII: 3Q9L08K71N)  
Oleanolic Acid (UNII: 6SMK8R7TGJ)  
Palmitoyl Lysyldioxymethionyllysine (UNII: T7A529FB8O)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
SOY SPHINGOLIPIDS (UNII: P491F5HP1U)  
Glycolic Acid (UNII: 0WT12SX38S)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Zinc Pidolate (UNII: C32PQ86DH4)  
Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N)  
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)  
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
Isohexadecane (UNII: 918X1OUF1E)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Masoprocol (UNII: 7BO8G1BYQU)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate (UNII: 7D4Q5YJ8NV)  
PEG-60 Almond Glycerides (UNII: 4Y0E651N0F)  
Propanediol (UNII: 5965N8W85T)  
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Xanthan Gum (UNII: TTV12P4NEE)  
Edetate Disodium (UNII: 7FLD91C86K)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Hydroxypropyl Betadex (UNII: 1I96OHX6EK)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Orange Oil (UNII: AKN3KSD11B)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58633-315-101 in 1 CARTON04/24/201506/01/2024
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58633-315-607 mL in 1 TUBE; Type 0: Not a Combination Product04/24/201506/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/24/201506/01/2024
Labeler - Dr. Dennis Gross Skincare™, LLC (008190808)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX010297942MANUFACTURE(58633-315) , PACK(58633-315)

Revised: 5/2024
Document Id: 27ddcf7f-24e1-48f9-bda4-2afaf059851d
Set id: 986bfc6d-fe2f-4604-8637-778298807f87
Version: 2
Effective Time: 20240507
 
Dr. Dennis Gross Skincare™, LLC