Avobenzone, Homosalate, Octisalate, and Octocrylene

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-06-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:30:05

Label at a glance#

ProductAveeno POSITIVELY RADIANT sheer daily moisturizer sunscreen BROAD SPECTRUM SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 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

For sunscreen use: apply generously and evenly 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 higher and other sun protection measures including: lim...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone (1.5%)Sunscreen
Homosalate (5%)Sunscreen
Octisalate (4%)Sunscreen
Octocrylene (6%)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 external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply generously and evenly 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 higher and other sun protection 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylyl Methicone, Glycerin, Methyl Methacrylate Crosspolymer, Glycine Soja (Soybean) Seed Extract, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Pentylene Glycol, Hydroxyacetophenone, Fragrance, Phenoxyethanol, Glyceryl Stearate, Polyacrylate-13, Chlorphenesin, Tocopheryl Acetate, Steareth-21, Polyisobutene, Disodium EDTA, Silica, Polysorbate 20, Sodium Hydroxide, Titanium Dioxide, Mica

Questions or comments?

OTC - QUESTIONS SECTION

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMATOLOGIST RECOMMENDED
Aveeno®
POSITIVELY
RADIANT ®

SHEER
HYDRATION
sheer daily
moisturizer

sunscreen
BROAD SPECTRUM
SPF 30
clinically proven
to even skin tone
and texture
TOTAL SOY
COMPLEX

2.5 fl oz (73 mL)

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-047069968-0470-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
fdfaf8c6-6685-3bd9-e053-6394a90a5666b6a37439-e67d-4e53-8659-1d083c56580f2023-06-12WarningsExact identifier
spl id: fdfaf8c6-6685-3bd9-e053-6394a90a5666
spl set id: b6a37439-e67d-4e53-8659-1d083c56580f

Reported adverse events (FAERS/openFDA)#

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