DARK FOUNDATION SPF 15- titanium dioxide, zinc oxide powder

Dark Foundation SPF 15 by

Drug Labeling and Warnings

Dark Foundation SPF 15 by is a Otc medication manufactured, distributed, or labeled by Ei Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 20%
Titanium Dioxide 7%

Purpose

Sunscreen
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

• Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
• This product has been shown only to help prevent sunburn, not skin cancer or early aging
• For External use only
• Do not use on damage or broken skin
• When using this product keep out of eyes. Rinse with water to remove
• Stop use and ask doctor if rash occurs
• Keep out of reach of children
• If product is swallowed get medical help or contact a poison control center right away
  

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water-resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a a sunscreen with a broad spectrum SPF 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 sleeve shirts, pants, hats, and sunglasses
• Children under 6 month: ask a doctor
  

Inactive Ingredients

Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide

Questions or Comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DARK FOUNDATION SPF 15 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52512-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52512-501-08	72 in 1 CASE
1		8 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/16/2012

Labeler - Ei Inc. (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Ei Inc.		105803274	manufacture(52512-501) , label(52512-501) , pack(52512-501)