FDA.reportPublic FDA data

Original Beauty Lotion SPF15 Mountain Falls 909.005 909AE

Manufacturer
Vi-Jon, LLC
Effective date
2022-05-18
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
legacy-cache
Hydrated at
2026-08-01 22:00:52

Label at a glance#

ProductOctinoxate, Zinc Oxide
Active ingredientOctinoxate, Zinc Oxide
Label structure15 sections

Indications and uses

helps prevent sunburn if used as diected 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 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 as sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, espcially ...

Storage and handling

protect the product from excessive heat and direct sun

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 diected 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 external 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 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 as sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, espcially 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

STORAGE AND HANDLING SECTION

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, cylopentasiloxane, cyclohexasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium Herbaceum (cotton) seed oil, behenyl alcohol, cetyl alcohol, DMDM hydantoin, iodopropynyl butylcarbamate, fragrance, tocopheryl acetate, disodium EDTA, steareth-2, oleth-3 phosphate, ascorbic acid, panthenol

disclaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Procter & Gamble,

distributor of Olay All Day Moisturizer with sunscreen.

Adverse reactions

ADVERSE REACTIONS SECTION

This product is not manufacture or distributed by Procter & Gamble,

distributor of Olay All Day Moisturizer with sunscreen

adverse reaction

ADVERSE REACTIONS SECTION

Manufactured by: Vi-Jon, LLC

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mountain

falls

Compare

to Olay

won't

clog Pores

UVA/UVB

protection

vitamin

E & C

enriched

SPF

15

moisturizing

beuty 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 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-09090869-0909-26, 0869-0909-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIM
Water059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
POLYSORBATE 806OZP39ZG8HIACT
LAURETH-7Z95S6G8201IACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PEG/PPG-20/20 DIMETHICONEBA94B7CK8KIACT
STEARETH-2153J3F32P58IACT
STEARYL ALCOHOL2KR89I4H1YIACT
LEVANT COTTONSEED OILN5CFT140R8IACT
DOCOSANOL9G1OE216XYIACT
CETYL ALCOHOL936JST6JCNIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
STEARETH-2V56DFE46J5IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
PANTHENOLWV9CM0O67ZIACT

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
10f6bacc-3daf-e480-e063-6394a90a3fcf212081e8-e805-4a51-8f6e-49fe9c720ee42024-02-09Warnings, Adverse reactionsExact identifier
spl set id: 212081e8-e805-4a51-8f6e-49fe9c720ee4

Reported adverse events (FAERS/openFDA)#

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