OTC Medication Information: Complete Beauty

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.

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

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)

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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 (OCTINOXATE) OCTINOXATE 60 mg in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
ISOHEXADECANE
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
POLYSORBATE 80
LAURETH-7
PEG/PPG-20/20 DIMETHICONE
STEARETH-21
STEARYL ALCOHOL
LEVANT COTTONSEED OIL
DOCOSANOL
.ALPHA.-TOCOPHEROL ACETATE
CETYL ALCOHOL
STEARETH-2
EDETATE DISODIUM ANHYDROUS
ALOE VERA LEAF
OLETH-3 PHOSPHATE
BENZYL ALCOHOL
CHLORPHENESIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41190-503-26 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41190-503-26)
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, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (41190-503)

Revised: 06/2022 Wakefern Food Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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