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

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

Drug Labeling and Warnings

Dr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 ℮

INGREDIENTS AND APPEARANCE

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

Product 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)