Other
Drug Facts
Dist. by SPOOGE LLC.
3495 Lakeside Dr #255 Reno, NV 89509
Dew Me Lotion
FDA Label NDC 85385-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spooge for the product Dew Me (NDC 85385-135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
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).
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
Principal Display Panel (50 ML Tube Box)
* Please review the disclaimer below.
