COMPLETE BEAUTY- octinoxate and zinc oxide lotion 
Wakefern Food Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Extra back panel claims

Complete

beauty lotion

all day moisturizer

Broad Sptctrum SPF 15

Sunscreen

ShopRite

Active ingredients

Active ingredients

Octinoxate 6.0%

Zinc Oxide 3.0%

Purpose

Purpose

Sunscreen

Use

Uses

Warnings

Warnings

For external use only

Do not use

Do not use on damaged or broken skin


When using this product

When using this product keep out of eyes. rinse with water to remove

Stop use

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

other information

Other information

Inactive ingredients

Inactive ingredients water, glycerin, isohexadecan, polysorbate 80, sodium acrylate/acryloyldimethyl taurate copolymer, laureth-7, cyclopentasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, gossypium herbaceum (cotton) seen oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, DMDM hydantoin, itodpropynyl butylcarbamate, steareth-2, disodium EDTA, aloe barbadensis leaf extract, oleth-3 phosphate

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

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)

image description

COMPLETE BEAUTY 
octinoxate, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41190-503
Route of Administration TOPICAL DEA Schedule     
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)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
LAURETH-7 (UNII: Z95S6G8201)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
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)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
STEARETH-2 (UNII: V56DFE46J5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41190-503-26 1 in 1 CARTON
1 118 mL in 1 BOTTLE, PLASTIC
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)

Revised: 1/2013
Document Id: ce7404cf-327a-4ae0-bbc7-f54ddeca13d2
Set id: 40f188dd-7bc0-4f42-b1f5-11af6a967bac
Version: 2
Effective Time: 20130124
 
Wakefern Food Corporation