FDA.reportPublic FDA data

Complete Beauty Lotion SPF 15 503.002/503AB

Manufacturer
Vi-Jon, LLC
Effective date
2023-07-26
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:27:58

Label at a glance#

ProductComplete Beauty
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure14 sections

Indications and 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

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistat 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially fr...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.0%

Zinc oxide 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For exteral use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistat 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. to 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

Other information

  • protect the product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

disclaimer

SPL UNCLASSIFIED SECTION

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

Adverse reactions

ADVERSE REACTIONS SECTION

Manufactured by: Vi-Jon, Inc., St. Louis, Mo 63114

Questions or Comments? 1-888-593-0593

Made in the USA

with US and foreign parts

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mountain

falls

*Compare to Olay

won't clog pores

vitamin E

and aloe

fragrance free

spf 15

sensitive skin

beauty lotion

broad spectrum

SPF 15 sunscreen

6 FL OZ (177 mL)

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-05030869-0503-30, 0869-0503-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
POLYSORBATE 806OZP39ZG8HIACT
LAURETH-7Z95S6G8201IACT
PEG/PPG-20/20 DIMETHICONEBA94B7CK8KIACT
steareth-2153J3F32P58IACT
STEARYL ALCOHOL2KR89I4H1YIACT
LEVANT COTTONSEED OILN5CFT140R8IACT
DOCOSANOL9G1OE216XYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETYL ALCOHOL936JST6JCNIACT
STEARETH-2V56DFE46J5IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALOE VERA LEAFZY81Z83H0XIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
BENZYL ALCOHOLLKG8494WBHIACT
CHLORPHENESINI670DAL4SZIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10a88b7f-ceaf-b9bb-e063-6294a90ac831c726f345-4a02-433f-99db-fe0e6273c6862024-02-05Warnings, Adverse reactionsExact identifier
spl set id: c726f345-4a02-433f-99db-fe0e6273c686

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.