Label: DARK SPOT SUN DEFENSE BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58633-315-10, 58633-315-60 - Packager: Dr. Dennis Gross Skincare™, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated April 30, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
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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?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
DARK SPOT SUN DEFENSE BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide creamProduct 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)
