OLAY COMPLETE UV365 DAILY MOISTURIZER SENSITIVE BROAD SPECTRUM SPF 15- octinoxate and zinc oxide lotion

Olay Complete UV365 Daily Moisturizer Sensitive by

Drug Labeling and Warnings

Olay Complete UV365 Daily Moisturizer Sensitive 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
Octinoxate 6%	Sunscreen
Zinc Oxide 3%	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, isohexadecane, aloe barbadensis leaf extract, tocopheryl acetate, steareth-21, cyclopentasiloxane, polyacrylamide, stearyl alcohol, C13-14 isoparaffin, behenyl alcohol, DMDM hydantoin, cetyl alcohol, PEG/PPG-20/20 dimethicone, laureth-7, steareth-2, disodium EDTA, triethoxycaprylylsilane, oleth-3 phosphate, BHT, iodopropynyl butylcarbamate.

Questions or comments?

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Distr. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

OLAY ®

COMPLETE

15

UV365 Daily Moisturizer

with Sunscreen

BROAD SPECTRUM SPF 15
SENSITIVE

177 mL (6.0 FL OZ)

INGREDIENTS AND APPEARANCE

OLAY COMPLETE UV365 DAILY MOISTURIZER SENSITIVE  BROAD SPECTRUM SPF 15
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-194
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-21 (UNII: 53J3F32P58)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)
STEARETH-2 (UNII: V56DFE46J5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-7 (UNII: Z95S6G8201)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-194-12	1 in 1 CARTON	09/11/2017
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 69423-194-17	1 in 1 CARTON	09/11/2017
2		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 69423-194-50	1 in 1 CARTON	09/11/2017
3		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 69423-194-01	0.5 mL in 1 POUCH; Type 0: Not a Combination Product	09/11/2017
5	NDC: 69423-194-02	2 in 1 BLISTER PACK	02/03/2020
5		1 in 1 CARTON
5		177 mL in 1 BOTTLE, PLASTIC; 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(69423-194) , pack(69423-194)