OTC Medication Information: Tan Foundation SPF 15

TAN FOUNDATION SPF 15 — zinc oxide and titanium dioxide powder
Bare Escentuals Beauty Inc.

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.

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, Zinc Oxide

Questions or Comments?

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Label
(click image for full-size original)
TAN FOUNDATION SPF 15
titanium dioxide, zinc oxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-883
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (Zinc Oxide) Zinc Oxide 20 g in 100 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 7 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MICA
BISMUTH OXYCHLORIDE
FERROSOFERRIC OXIDE
BROWN IRON OXIDE
FERRIC OXIDE YELLOW
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:98132-883-08 72 JAR (JAR) in 1 CASE contains a JAR
1 8 g in 1 JAR This package is contained within the CASE (98132-883-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/16/2012
Labeler — Bare Escentuals Beauty Inc. (087008363)
Registrant — Ei Inc. (105803274)
Establishment
Name Address ID/FEI Operations
Ei Inc. 105803274 manufacture, label, pack

Revised: 06/2012 Bare Escentuals Beauty Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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