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
DARK SPOT SUN DEFENSE
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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.
https://otclabels.com/lib/otc/otc-meds/dark-spot-sun-defense-broad-spectrum-spf-50/