OLAY TOTAL EFFECTS MOISTURIZER BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Olay Total Effects Moisturizer by

Drug Labeling and Warnings

Olay Total Effects 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
Avobenzone 3.0%
Homosalate 9.0%
Octisalate 4.5%
Octocrylene 6.0%

PURPOSE

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*, pentylene glycol, panthenol**, tocopheryl acetate***, sodium ascorbyl phosphate^, retinyl propionate^^, camellia sinensis leaf extract^*, BHT^**, dimethicone, 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, titanium dioxide, polymethylsilsesquioxane, benzyl alcohol, methylparaben, ethylparaben, propylparaben, iodopropynyl butylcarbamate, fragrance

*Vitamin B3, **Pro-Vitamin B5, ***Vitamin E, ^Vitamin C, ^^Vitamin A,

^*Green Tea Antioxidant, ^**Antioxidant

Questions or comments?

Call 1-800-285-5170

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Distr. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

OLAY ®

TOTaL effeCTS ®

SPF30

7 IN
ONE

moisturizer with sunscreen

BROAD SPECTRUM SPF 30

50 mL (1.7 FL OZ)

INGREDIENTS AND APPEARANCE

OLAY TOTAL EFFECTS MOISTURIZER  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-389
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	9 g  in 100 mL
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

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
RETINYL PROPIONATE (UNII: 32JK994WMC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PALMITIC ACID (UNII: 2V16EO95H1)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-389-50	1 in 1 CARTON	08/13/2019
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	08/13/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)