Label: DR. DENNIS GROSS SKINCARE - LIGHTWEIGHT WRINKLE DEFENSE BROAD SPECTRUM SPF 30- zinc oxide liquid
- NDC Code(s): 66163-4272-1, 66163-4272-2, 66163-4272-3, 66163-4272-4
- Packager: Cosmetic Solutions LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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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 of age: 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 the 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
Water/Aqua/Eau, Butyloctyl Salicylate, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Coconut Alkanes, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Vaccinium Vitis-Idaea (Lingonberry) Fruit Extract, Ferulic Acid, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Arctostaphylos Uva-Ursi (Bearberry) Leaf Extract, Aloe Barbadensis Leaf Juice, Quercetin, Tocopherol, Tocopheryl Acetate, Xanthophylls (Lutein), Sucrose, Ethylhexylglycerin, Lecithin, Polyglutamic Acid, Tapioca Starch, Calcium Gluconate, Dimethicone/Polyglycerin-3 Crosspolymer, Triheptanoin, Xanthan Gum, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Triethoxycaprylylsilane, Polymethylsilsesquioxane, Propanediol, C13-15 Alkane, Dipropylene Glycol, Sodium Hydroxide, Disteardimonium Hectorite, Isostearyl Lactate, Triethyl Citrate, Sodium Chloride, Tetrasodium Glutamate Diacetate, Gluconolactone, Sodium Citrate, Citric Acid, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate
- Questions?
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
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INGREDIENTS AND APPEARANCE
DR. DENNIS GROSS SKINCARE - LIGHTWEIGHT WRINKLE DEFENSE BROAD SPECTRUM SPF 30
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-4272 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 16 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Dimethicone (UNII: 92RU3N3Y1O) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Glycerin (UNII: PDC6A3C0OX) Coconut Alkanes (UNII: 1E5KJY107T) Lingonberry (UNII: 0UNK9RZQ7X) Ferulic Acid (UNII: AVM951ZWST) Aloe Vera Leaf (UNII: ZY81Z83H0X) Quercetin (UNII: 9IKM0I5T1E) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Lutein (UNII: X72A60C9MT) Starch, Tapioca (UNII: 24SC3U704I) Calcium Gluconate (UNII: SQE6VB453K) Triheptanoin (UNII: 2P6O7CFW5K) Xanthan Gum (UNII: TTV12P4NEE) Cocoyl Caprylocaprate (UNII: 8D9H4QU99H) Triethoxycaprylylsilane (UNII: LDC331P08E) Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69) Propanediol (UNII: 5965N8W85T) C13-15 Alkane (UNII: 114P5I43UJ) Dipropylene Glycol (UNII: E107L85C40) Sodium Hydroxide (UNII: 55X04QC32I) Disteardimonium Hectorite (UNII: X687XDK09L) Isostearyl Lactate (UNII: 8OM3O3YPML) Triethyl Citrate (UNII: 8Z96QXD6UM) Sodium Chloride (UNII: 451W47IQ8X) Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY) Gluconolactone (UNII: WQ29KQ9POT) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Citric Acid Monohydrate (UNII: 2968PHW8QP) Phenoxyethanol (UNII: HIE492ZZ3T) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66163-4272-1 15 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 2 NDC:66163-4272-2 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 3 NDC:66163-4272-3 50 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 4 NDC:66163-4272-4 7 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2021 Labeler - Cosmetic Solutions LLC (807907928)
