Derm Dude Never Fade Tattoo Brightening Sunscreen

Derm Dude Brightening Sunscreen SPF 50 by

Drug Labeling and Warnings

Derm Dude Brightening Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERM DUDE BRIGHTENING SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion 
Spa de Soleil

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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Derm Dude Never Fade Tattoo Brightening Sunscreen

Active Ingredients

Zinc Oxide 9.0%

Titanium Dioxide 7.8%

Purpose

Sunscreen

Warnings

Warnings

For external use only. Do not use on broken or damaged skin. When using this product

• keep out of eyes
• rinse with water to remove
• stop use and ask a doctor if rash or irritation develops
• for external use onlyl
• keep out of reach of children

Directions

Directions: Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Massage well. Allow complete penetration. Reapply at least every 2 hours & immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & other sun protection measures including: limit time in the sun, especially from 10 a.m.- 2 p.m., wear long-sleeve shirts, pants, hats, & sunglasses. Children under 6 months. Ask a doctor.

Inactive Ingredients

Carthamus Tinctorius (Safflower) Seed Oil, Coconut Alkanes, Coco Caprylate/Caprate, Caprylic/Capric Triglyceride, Stearic Acid, Alumina, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Pongamia Glabra Seed (Karanja) Oil, Vitis Vinifera (Grape) Seed Oil, Olea Europaea (Olive) Oil, Argania Spinsosa (Argan) Oil, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Extract, Tocopherol, Argania Spinosa Kernel Oil, Tocopheryl Acetate (Vitamin E), Bisabolol, *Squalane* From Sugarcane

Principal Display Panel

DERM DUDE BRIGHTENING SUNSCREEN SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.2 mg  in 113 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.8 mg  in 113 mL

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
COCONUT ALKANES (UNII: 1E5KJY107T)
SAFFLOWER OIL (UNII: 65UEH262IS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9002-1	113 mL in 1 TUBE; Type 0: Not a Combination Product	10/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/06/2021	01/08/2023

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9002)

Revised: 1/2023

Document Id: f1c7d120-5bea-d806-e053-2995a90a2257

34390-5

Set id: cdb3a45f-78cf-df55-e053-2995a90adc50

Version: 2

Effective Time: 20230108