Octinoxate, Octisalate, Avobenzone

Manufacturer
Vi-Jon
Effective date
2022-11-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:47:14

Label at a glance#

ProductOctinoxate, Octisalate, Avobenzone
Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the rise 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 a sunscreen with a Broad Spectrum SPF value of 15 or highter and other sun protection measures including: limit the time in the sun, e...

Storage and handling

protect the product from excessive heat and direct sun may stain some fabrics

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 5.0%

Avobenzone 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 rise 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove.

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 a sunscreen with a Broad Spectrum SPF value of 15 or highter and other sun protection measures including:
  • limit the 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

STORAGE AND HANDLING SECTION

  • protect the product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, diisopropyl adipate, cyclomethicone, glycerin, undecylcrylene dimethicone, glyceryl stearate, PEG-100 stearate, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, tocopyeryl acetate, carbomer, disodium EDTA, trietanoolamine, potassium sorbate

claims

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Galdema Laboatories, L.P.,  distributor of Cetaphil Daily Facial Moisturizer SPF 15

Manufactured by: Vi-Jon, Inc.,

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#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-09950869-0995-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
10f84fd6-228e-54c9-e063-6394a90aab16eeb04e82-0a5c-40ca-8cc2-eadd7451eca12024-02-09WarningsExact identifier
spl set id: eeb04e82-0a5c-40ca-8cc2-eadd7451eca1

Reported adverse events (FAERS/openFDA)#

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