DARK SPOT SUN DEFENSE BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide cream

Dark Spot Sun Defense by

Drug Labeling and Warnings

Dark Spot Sun Defense by is a Otc medication manufactured, distributed, or labeled by Dr. Dennis Gross Skincare™, LLC, PhytogenX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

• 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

INGREDIENTS AND APPEARANCE

DARK SPOT SUN DEFENSE   BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58633-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	49 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	44.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 .Beta.-Cyclodextrin (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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58633-315-10	1 in 1 CARTON
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58633-315-60	7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/24/2015

Labeler - Dr. Dennis Gross Skincare™, LLC (008190808)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX		010297942	MANUFACTURE(58633-315) , PACK(58633-315)