OLAY REGENERIST REGENERATING ADVANCED ANTI-AGING MOISTURIZE BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Olay Regenerist Regenerating Advanced Anti-Aging Moisturize by

Drug Labeling and Warnings

Olay Regenerist Regenerating Advanced Anti-Aging Moisturize 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 15.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Octocrylene 2.7%	Sunscreen
Oxybenzone 6.0%	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, polymethylsilsesquioxane, niacinamide*, polyethylene, pentylene glycol, palmitoyl pentapeptide-4**, panthenol***, ascorbic acid^, tocopheryl acetate^^, camellia sinensis leaf extract^^^, allantoin, carnosine, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, benzyl alcohol, stearyl alcohol, behenyl alcohol, PEG-100 stearate, cetyl alcohol, methylparaben, fragrance, propylparaben, ethylparaben, cetearyl glucoside, cetearyl alcohol, dimethiconol, disodium EDTA, stearic acid, palmitic acid, iodopropynyl butylcarbamate.

Questions or comments?

Call 1-800-285-5170

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Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

OLAY®

REGENERIST

ADVANCED ANTI-AGING

50

regenerating lotion

with sunscreen

BROAD SPECTRUM SPF 50

MOISTURIZE

1.7 FL OZ (50 mL)

INGREDIENTS AND APPEARANCE

OLAY REGENERIST REGENERATING ADVANCED ANTI-AGING MOISTURIZE  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PALMITIC ACID (UNII: 2V16EO95H1)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
CARNOSINE (UNII: 8HO6PVN24W)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALLANTOIN (UNII: 344S277G0Z)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PEG-100 STEARATE (UNII: YD01N1999R)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-125-50	1 in 1 CARTON	11/01/2016
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	11/01/2016

Labeler - The Procter & Gamble Manufacturing Company (004238200)