OLAY TOTAL EFFECTS CC TONE CORRECTING BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM- avobenzone, octisalate, and octocrylene cream

Olay Total Effects CC Tone Correcting by

Drug Labeling and Warnings

Olay Total Effects CC Tone Correcting by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 2%	Sunscreen
Octisalate 3%	Sunscreen
Octocrylene 3%	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, niacinamide*, titanium dioxide, isopropyl lauroyl sarcosinate, acetyl glucosamine, panthenol**, tocopheryl acetate***, dimethicone, caprylyl glycol, dimethiconol, C13-14 isoparaffin, cetearyl glucoside, cetearyl alcohol, laureth-7, stearyl alcohol, behenyl alcohol, cetyl alcohol, carbomer, polyacrylamide, aminomethyl propanol, citric acid, PEG-100 stearate, 1,2-hexanediol, phenoxyethanol, sodium benzoate, iron oxides.

*Vitamin B3, **Vitamin B5, ***Vitamin E

Questions or comments?

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Distr. by
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

COLOR +
CORRECTION

CC CREAM

OLAY ®

Total Effects ®

7
IN
ONE

CC

TONE CORRECTING

15

MOISTURIZER with sunscreen

BROAD SPECTRUM SPF 15

light to medium

50 mL (1.7 FL OZ)

INGREDIENTS AND APPEARANCE

OLAY TOTAL EFFECTS CC TONE CORRECTING  BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DOCOSANOL (UNII: 9G1OE216XY)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURETH-7 (UNII: Z95S6G8201)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-355-50	1 in 1 CARTON	11/07/2013
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/07/2013

Labeler - The Procter & Gamble Manufacturing Company (004238200)