FDA.reportPublic FDA data

Titanium Dioxide and Zinc Oxide

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:41:22

Label at a glance#

ProductAveeno Positively Mineral Sensitive Skin Face Milk Sunscreen Broad Spectrum SPF 40 Plus
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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

apply liberally 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...

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
Titanium Dioxide (4.9%)Sunscreen
Zinc Oxide (2.9%)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 liberally 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, Trisiloxane, Styrene/Acrylates Copolymer, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, PPG-12/SMDI Copolymer, Bisabolol, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Magnesium Sulfate, DMDM Hydantoin, Triethoxycaprylylsilane, BHT

Questions?

OTC - QUESTIONS SECTION

Call toll-free 866-428-3366 or 215-273-8755 (collect). www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno ®
POSITIVELY
MINERAL ™
sensitive skin

face milk
sunscreen

BROAD SPECTRUM
SPF 40+
1.4 fl oz (40 mL)

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label

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
69968-058169968-0581-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
TRISILOXANE9G1ZW13R0GIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
LEVOMENOL24WE03BX2TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DMDM HYDANTOINBYR0546TOWIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT

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
f2763b21-0ad8-7129-e053-2a95a90a303c6d5ed8e0-74af-4a50-8fa4-c9786a2dbfed2023-01-17WarningsExact identifier
spl set id: 6d5ed8e0-74af-4a50-8fa4-c9786a2dbfed

Reported adverse events (FAERS/openFDA)#

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