OTC Medication Information: Dark Spot Sun Defense Broad Spectrum SPF 50

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

PRINCIPAL DISPLAY PANEL -- 50 mL Tube Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 49 mg in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 44.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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
Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate
PEG-60 Almond Glycerides
Propanediol
Isopropyl Titanium Triisostearate
Butylated Hydroxytoluene
Polysorbate 60
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)
Polyhydroxystearic Acid (2300 MW)
Xanthan Gum
Edetate Disodium
Citric Acid Monohydrate
Hydroxypropyl .Beta.-Cyclodextrin
Sodium Citrate
Stearic Acid
Phenoxyethanol
Benzyl Alcohol
Potassium Sorbate
Sodium Benzoate
Orange Oil
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58633-315-10 1 TUBE in 1 CARTON contains a TUBE
1 50 mL in 1 TUBE This package is contained within the CARTON (58633-315-10)
2 NDC:58633-315-60 7 mL in 1 TUBE None
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 Operations
PhytogenX 010297942 MANUFACTURE (58633-315), PACK (58633-315)

Revised: 04/2015 Dr. Dennis Gross Skincare™, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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