DEW ME- zinc oxide lotion

Dew Me by

Drug Labeling and Warnings

Dew Me by is a Otc medication manufactured, distributed, or labeled by Spooge, Sun Deep, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc Oxide 22%.

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 reach of children. In case of ingestion, get medical help or contact a poison control center. Children under 6 months of age- ask a doctor.

Directions

+ Apply liberally 20 min before sun exposure and at least every two hours. Otherwise, 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 broad spectrum SPF 15 or higher and other sun protection measures including:

+ limit time in the sun, especially from 10am-2pm.

* wear long sleeved shirts, pants, hats and sunglasses.

Other information

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

Inactive ingredients

Hyaluronic Acid, Glycerin, Bisabolol, Pongamia Pinnata Seed Extract, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Niacinamide, Allantoin, Water, Butyloctyl Salicylate, Tridecy| Salicylate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Methyihepty! Isostearate, Polyglyceryl-10 Stearate, Polyglyceryl-4 Diisostearate/Polyhydroxysteatate/Sebacate, Caprylic/Capric Triglyceride, Polyglyceryl-2 Dipolyhydroxystearate, Glyceryl Caprylate, Sorbitan Sesquioleate, Lecithin, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Silica, Iron Oxides (CI 77491), Iron Oxides (C! 77492), Iron Oxides (CI77499, Fragrance (Sea Salt & Sage ORC2402697).

SPL UNCLASSIFIED SECTION

Dist. by SPOOGE LLC.
3495 Lakeside Dr #255 Reno, NV 89509

PRINCIPAL DISPLAY PANEL - 50 ML Tube Box

DEW
ME

YOU DO YOU, I'LL DEW ME

DEWY TINTED MINERAL
ALL-SCREEN WITH NIACINAMIDE
+ HYALURONIC ACID

SPOOGE™

USE PROTECTION
DERMATOLOGIST DEVELOPED

1.7 FL OZ / 50 ML

INGREDIENTS AND APPEARANCE

DEW ME 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85385-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Hyaluronic Acid (UNII: S270N0TRQY)
Glycerin (UNII: PDC6A3C0OX)
LEVOMENOL (UNII: 24WE03BX2T)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
Tocopherol (UNII: R0ZB2556P8)
JOJOBA OIL (UNII: 724GKU717M)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
Niacinamide (UNII: 25X51I8RD4)
Allantoin (UNII: 344S277G0Z)
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Propanediol (UNII: 5965N8W85T)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
Polyglyceryl-10 Stearate (UNII: 90TF85HH91)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85385-135-01	1 in 1 BOX	06/25/2025
1		50 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 drug	M020	06/25/2025

Labeler - Spooge (135771317)

Registrant - Sun Deep, Inc. (189788201)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep, Inc.		189788201	MANUFACTURE(85385-135)