DR. DENNIS GROSS SKINCARE - LIGHTWEIGHT WRINKLE DEFENSE BROAD SPECTRUM SPF 30- zinc oxide liquid 
Cosmetic Solutions 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.

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Dr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30

Drug Facts

Active ingredient

Zinc Oxide 16%

Purpose

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 the reach of children. If swallowed, get medical help or contact a Poison Center right away.

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
  • 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

  • Protect the product in this container from excessive heat and direct sun

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?

Call 1-888-830-7546
Monday through Friday, 9:00 AM to 5:00 PM EST

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

Dr Dennis Gross

All-Physical

Lightweight
Wrinkle Defense

Broad Spectrum
Sunscreen SPF 30

Oil-Free / Reef Safe

You want: Defense against
harmful sun damage

1.7 fl oz/50ml ℮

Principal Display Panel - 50 ml Tube Carton
DR. DENNIS GROSS SKINCARE - LIGHTWEIGHT WRINKLE DEFENSE BROAD SPECTRUM SPF 30 
zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4272
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide16 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-4272-115 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2021
2NDC:66163-4272-230 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2021
3NDC:66163-4272-350 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2021
4NDC:66163-4272-47 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2021
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 1/2023
 
Cosmetic Solutions LLC