OLAY COMPLETE NORMAL UV365 DAILY MOISTURE WITH SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, and octocrylene cream

Olay Complete Normal UV365 Daily Moisture with sunscreen by

Drug Labeling and Warnings

Olay Complete Normal UV365 Daily Moisture with sunscreen 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, dimethicone, isopropyl isostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, stearyl alcohol, propylene glycol, niacinamide, cetyl alcohol, behenyl alcohol, panthenol, tocopheryl acetate, caprylyl glycol, 1,2-hexanediol, phenoxyethanol, dimethiconol, PEG-100 stearate, fragrance, sodium benzoate, cetearyl glucoside, cetearyl alcohol, disodium EDTA, stearic acid, palmitic acid, ascorbic acid.

Questions or comments?

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 56 g Jar Carton

OLAYg

complete

Normal

15

UV365 DAILY MOISTURE CREAM WITH SUNSCREEN

BROAD SPECTRUM SPF 15

NET WT 56 g (2.0 OZ )

INGREDIENTS AND APPEARANCE

OLAY COMPLETE NORMAL UV365 DAILY MOISTURE WITH SUNSCREEN  BROAD SPECTRUM SPF 15
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-216
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-100 STEARATE (UNII: YD01N1999R)
PALMITIC ACID (UNII: 2V16EO95H1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-216-56	1 in 1 CARTON	09/11/2017
1		56 g in 1 JAR; 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	09/11/2017

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
The Procter & Gamble Manufacturing Company		017745779	manufacture(69423-216)