RxNorm Names
Not yet provided
GOLDEN DARK FOUNDATION SPF 15
(titanium dioxide, zinc oxide)
powder
[Bare Escentuals Beauty Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6082a2a3-35bf-4d21-a233-8a56b688c011| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
NOTE: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.
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
| GOLDEN DARK FOUNDATION SPF 15
titanium dioxide, zinc oxide powder |
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| Labeler - Bare Escentuals Beauty Inc. (087008363) |
| Registrant - Ei Inc. (105803274) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Ei Inc. | 105803274 | manufacture(98132-890), label(98132-890), pack(98132-890) | |
Revised: 02/2013
Document Id: 3b6f890b-9ec7-4fa2-a3f8-1d24233cd35d
Set id: 6082a2a3-35bf-4d21-a233-8a56b688c011
Version: 2
Effective Time: 20130201
Bare Escentuals Beauty Inc.


