OLAY REGENERIST REGENERATING MOISTURIZER BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, and octocrylene lotion

Olay Regenerist Regenerating Moisturizer by

Drug Labeling and Warnings

Olay Regenerist Regenerating Moisturizer 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 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, niacinamide*, polymethylsilsesquioxane, dimethicone, isopropyl isostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, panthenol**, palmitoyl pentapeptide-4***, tocopheryl acetate^, camellia sinensis leaf extract^^, ascorbic acid^^^, allantoin, PTFE, titanium dioxide, stearyl alcohol, caprylyl glycol, behenyl alcohol, 1,2-hexanediol, phenoxyethanol, cetyl alcohol, dimethiconol, PEG-100 stearate, fragrance, sodium benzoate, cetearyl glucoside, cetearyl alcohol, sodium PEG-7 olive oil carboxylate, BHT, disodium EDTA, stearic acid, palmitic acid

Questions or comments?

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Distr. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

OLAY ®

REGENERIST ®

REGENERATING LOTION

WITH SUNSCREEN

15

ADVANCED ANTI-AGING

MOISTURIZE

BROAD SPECTRUM SPF 15

2.5 FL OZ (75 mL)

INGREDIENTS AND APPEARANCE

OLAY REGENERIST REGENERATING MOISTURIZER  BROAD SPECTRUM SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
PANTHENOL (UNII: WV9CM0O67Z)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALLANTOIN (UNII: 344S277G0Z)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DOCOSANOL (UNII: 9G1OE216XY)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PEG-100 STEARATE (UNII: YD01N1999R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-049-75	1 in 1 CARTON	01/15/2015
1		75 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	01/15/2015

Labeler - The Procter & Gamble Manufacturing Company (004238200)