FDA.reportPublic FDA data

Aveeno ® POSITIVELY MINERAL™ sensitive skin sunscreen BROAD SPECTRUM SPF 50

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-02-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:37:06

Label at a glance#

ProductAveeno Positively Mineral Sensitive Skin Sunscreen for Face Broad Spectrum SPF 50
Active ingredientZINC OXIDE
Label structure11 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 generously and evenly 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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...

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

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (21.6%)

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 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

  • apply generously and evenly 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

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, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Styrene/Acrylates copolymer, Octyl dodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic acid, Silica, Ethyl methicone,Cetyl Dimethicone, Triethoxycaprylylsilane, Glyceryl Behenate, Sodium Chloride,Acrylates/Dimethicone copolymer, Chlorphenesin, Phenethyl alcohol, Avena Sativa (Oat) Kernel flour, Caprylyl Glycol,Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem juice, Tocopheryl Acetate

Questions

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 - 59 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMATOLOGIST
RECOMMENDED

Aveeno ®
POSITIVELY
MINERAL™
sensitive skin
sunscreen
BROAD SPECTURM SPF 50
FOR FACE

naturally-sourced
100% zinc oxide
active ingredient
sweat + water resistant
(80 min)
SPF

50

2.0 fl. oz (59 mL)

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-039469968-0394-2, 69968-0394-3

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
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
OCTYLDODECYL CITRATE CROSSPOLYMERX323T6QO4MIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ETHYL METHICONE (8 MPA.S)3YWG8XYT8HIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
SODIUM CHLORIDE451W47IQ8XIACT
CHLORPHENESINI670DAL4SZIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
OATMEAL8PI54V663YIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT
FEVERFEWZ64FK7P217IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB

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
f427abba-d10f-356d-e053-2a95a90a65c159c7060a-8cce-4ffa-addf-73d3ed6eca102023-02-07WarningsExact identifier
spl id: f427abba-d10f-356d-e053-2a95a90a65c1
spl set id: 59c7060a-8cce-4ffa-addf-73d3ed6eca10

Reported adverse events (FAERS/openFDA)#

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