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

Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15 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*, dimethicone, zea mays (corn) starch, isopropyl isostearate, panthenol**, palmitoyl pentapeptide-4***, caprylyl glycol, dimethiconol, cetearyl glucoside, cetearyl alcohol, stearic acid, palmitic acid, stearyl alcohol, cetyl alcohol, behenyl alcohol, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-100 stearate, 1,2-hexanediol, phenoxyethanol, fragrance

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 BROAD

SPECTRUM SPF 15

ADVANCED FACIAL

ANTI-AGING

MOISTURIZE

BROAD SPECTRUM SPF 15

75 mL (2.5 FL OZ)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-719
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	4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONOL (50000 CST) (UNII: R2285D73YT)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PALMITIC ACID (UNII: 2V16EO95H1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-719-75	1 in 1 CARTON	01/01/2023
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 Drug	M020	01/01/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)