COMPLETE BEAUTY- octinoxate, zinc oxide lotion

Complete Beauty by

Drug Labeling and Warnings

Complete Beauty by is a Otc medication manufactured, distributed, or labeled by Wakefern Food Corporation, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Extra back panel claims

Complete

beauty lotion

all day moisturizer

Broad Sptctrum SPF 15

with Vitamin E and Aloe

Sensitive Skin

light and non-greasy formula

Sunscreen

ShopRite

Active ingredients

Octinoxate 6.0%

Zinc Oxide 3.0%

Purpose

Sunscreen

Use

• helps prevent sunbrun
• 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 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 a water resistant sunscreen if swimming or sweating
• Sun Protection Measures, Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protections measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

other information

• protect the product from excessive heat and direct sun

Inactive ingredients

water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium herbaceum (cotton) seed oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, steareth-2, disodium EDTA, Aloe barbadensis leaf extract, oleth-3 phosphate, benzyl alcohol, chlorphenesin

Side Panel Claims

Broad spectrum SPF 15

Sunscreen

with vitaming E and aloe

Sensitive Skin

light and non-greasy lotion

ShopRite

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributer or Olay Complete All Day Moisture Lotion SPF 15

Adverse Reactions Section

DISTRIBUTED BY

WAKEFERN FOOD CORPORATION

5000 RIVERSIDE DRIVE,

KEASBEY, NJ O8832

1-800-SHOPRITE

www.shoprite.com

503.001/503AA

principal display panel

Compare to Olay Complete All Day Moisture Lotion SPF 15

complete

beauty

lotion

all day

moisturizer

Broad Spectrum SPF 15

Sunscreen

with vitamin E and aloe

Sensitive Skin

light and non-greasy lotion

ShopRite

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

COMPLETE BEAUTY 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LAURETH-7 (UNII: Z95S6G8201)
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)
STEARETH-21 (UNII: 53J3F32P58)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
DOCOSANOL (UNII: 9G1OE216XY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-2 (UNII: V56DFE46J5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-503-26	1 in 1 CARTON	01/09/2013
1		118 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 final	part352	01/09/2013

Labeler - Wakefern Food Corporation (069722418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41190-503)