OLAY COMPLETE TINTED MOISTURIZER  BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM- avobenzone, homosalate, octisalate, and octocrylene cream 
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.

----------

Olay® Complete Tinted Moisturizer
Broad Spectrum SPF 15 Light to Medium

Drug Facts

Active ingredientsPurpose
Avobenzone 3.0%Sunscreen
Homosalate 4.0%Sunscreen
Octisalate 4.5%Sunscreen
Octocrylene 2.6%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, polyethylene, dimethicone, titanium dioxide, isopropyl isostearate, stearyl alcohol, niacinamide, cetyl alcohol, behenyl alcohol, sorbitan stearate, aluminum starch octenylsuccinate, panthenol, tocopheryl acetate, benzyl alcohol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, isohexadecane, dimethiconol, PEG-100 stearate, ethylparaben, propylparaben, fragrance, stearic acid, sodium ascorbyl phosphate, cetearyl glucoside, cetearyl alcohol, polysorbate 60, iodopropynyl butylcarbamate, iron oxides.

Questions or comments?

Call 1-800-285-5170

Distr. by
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SolaSheer
TECHNOLOGY™

Olay®

COMPLETE

tinted moisturizer
with sunscreen

BROAD SPECTRUM SPF 15
Light-to-Medium

with vitamins B3, B5, C & E
48 hour hydration + Sheer Tint

OIL-FREE

1.7 FL OZ (50 mL)

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
OLAY COMPLETE TINTED MOISTURIZER   BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate4 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4.5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
high density polyethylene (UNII: UG00KM4WR7)  
dimethicone (UNII: 92RU3N3Y1O)  
titanium dioxide (UNII: 15FIX9V2JP)  
isopropyl isostearate (UNII: C67IXB9Y7T)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
niacinamide (UNII: 25X51I8RD4)  
cetyl alcohol (UNII: 936JST6JCN)  
docosanol (UNII: 9G1OE216XY)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
aluminum starch octenylsuccinate (UNII: I9PJ0O6294)  
panthenol (UNII: WV9CM0O67Z)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
benzyl alcohol (UNII: LKG8494WBH)  
methylparaben (UNII: A2I8C7HI9T)  
isohexadecane (UNII: 918X1OUF1E)  
PEG-100 stearate (UNII: YD01N1999R)  
ethylparaben (UNII: 14255EXE39)  
propylparaben (UNII: Z8IX2SC1OH)  
stearic acid (UNII: 4ELV7Z65AP)  
sodium ascorbyl phosphate (UNII: 836SJG51DR)  
cetearyl glucoside (UNII: 09FUA47KNA)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
polysorbate 60 (UNII: CAL22UVI4M)  
iodopropynyl butylcarbamate (UNII: 603P14DHEB)  
ferric oxide red (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-224-501 in 1 CARTON
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/19/201401/27/2017
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIBusiness Operations
The Procter & Gamble Manufacturing Company017745779MANUFACTURE(37000-224)

Revised: 8/2015
Document Id: db3df4d9-41c7-49fc-872a-30aced785c49
Set id: d19a4d7c-a05f-4c11-a5e4-f051abfce6a5
Version: 2
Effective Time: 20150820
 
Procter & Gamble Manufacturing Company