OLAY REGENERIST MICRO-SCULPTING ANTI-AGING MOISTURIZE BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, and octocrylene cream

Olay Regenerist Micro-Sculpting Anti-Aging Moisturize by

Drug Labeling and Warnings

Olay Regenerist Micro-Sculpting 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

AVOBENZONE 3.0%

HOMOSALATE 9.0%

OCTISALATE 4.5%

OCTOCRYLENE 6.0%

Sunscreen

Sunscreen

Sunscreen

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, tapioca starch, niacinamide*, panthenol**, tocopheryl acetate***, palmitoyl pentapeptide-4^, ceratonia

siliqua (carob) fruit extract, camellia sinensis leaf extract, dimethicone, caprylyl glycol, dimethiconol, cetearyl glucoside, cetearyl alcohol, sodium PEG-7 olive oil carboxylate, stearic acid, palmitic acid, stearyl alcohol, cetyl alcohol, behenyl alcohol, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-100 stearate, titanium dioxide, polymethylsilsesquioxane, 1,2-hexanediol, phenoxyethanol, iodopropynyl butylcarbamate, fragrance.

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

Olay®

REGENERIST ®

MICRO-SCUPLTING

CREAM
WITH SUNSCREEN

30

ADVANCED ANTI-AGING

MOISTURIZE

BROAD SPECTRUM SPF 30

50 mL (1.7 FL OZ)

INGREDIENTS AND APPEARANCE

OLAY REGENERIST MICRO-SCULPTING ANTI-AGING MOISTURIZE  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAROB (UNII: 5MG5Z946UO)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PALMITIC ACID (UNII: 2V16EO95H1)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
STARCH, TAPIOCA (UNII: 24SC3U704I)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-336-50	1 in 1 CARTON	02/01/2019
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 69423-336-15	1 in 1 CARTON	02/01/2019
2		15 mL in 1 TUBE; 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	02/01/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)