COVERGIRL SMOOTHERS TINTED MOISTURIZER  BB CREAM BROAD SPECTRUM SPF 15 (ALL SHADES)- octinoxate and zinc oxide liquid 
Procter & Gamble Manufacturing Company

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.

----------

Covergirl® Smoothers® Tinted Moisturizer
BB Cream Broad Spectrum SPF 15 (all shades)

Drug Facts

Active Ingredients

Octinoxate 6%
Zinc Oxide 3%

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
  • Do not use on damaged or broken skin

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a 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
  • reapply at least every 2 hours
  • use 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

  • protect this product from excessive heat and direct sun

Inactive ingredients

water, glycerin, isohexadecane, isopropyl palmitate, oleth-3 phosphate, sucrose polycottonseedate, tocopheryl acetate, iodopropynyl butylcarbamate, dmdm hydantoin, steareth-21, steareth-2, stearyl alcohol, behenyl alcohol, talc, polyacrylamide, dimethicone, dimethiconol, panthenol, c13-14 isoparaffin, disodium edta, bht, beta-carotene, methicone, cetyl alcohol, laureth-7, titanium dioxide, iron oxides.

Questions or comments?

Call 1-800-426-8374

PROCTER & GAMBLE, DISTR., HUNT VALLEY, MD 21030 USA

PRINCIPAL DISPLAY PANEL - 40 ml Tube Blister Pack

cgsmoothers®

805
fair to light

COVERGIRL

10in1
instant
skin
enhancer

40 ml (1.35 fl oz)

PRINCIPAL DISPLAY PANEL - 40 ml Tube Blister Pack
COVERGIRL SMOOTHERS TINTED MOISTURIZER   BB CREAM BROAD SPECTRUM SPF 15 (ALL SHADES)
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-756
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate60 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
glycerin 
isohexadecane 
isopropyl palmitate 
oleth-3 phosphate 
.alpha.-tocopherol acetate 
iodopropynyl butylcarbamate 
dmdm hydantoin 
steareth-21 
steareth-2 
stearyl alcohol 
docosanol 
talc 
dimethicone 
panthenol 
c13-14 isoparaffin 
edetate disodium 
butylated hydroxytoluene 
.beta.-carotene 
cetyl alcohol 
laureth-7 
titanium dioxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-756-401 in 1 BLISTER PACK
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/12/2012
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetica Laboratories Inc.255080491MANUFACTURE(37000-756)

Revised: 1/2013
Document Id: e2da8f47-9e87-4014-93cf-8c33e958a3ea
Set id: 9a7b193f-9225-41b0-bc35-a47521dafbf4
Version: 1
Effective Time: 20130116
 
Procter & Gamble Manufacturing Company