FDA.reportPublic FDA data

Aveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 30

Manufacturer
Kenvue Brands LLC
Effective date
2025-08-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:35:10

Label at a glance#

ProductAveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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 (6.5%)Sunscreen
Zinc Oxide (18.7%)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

When using this product

OTC - WHEN USING SECTION

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, Isohexadecane, C12-15 Alkyl Benzoate, Ethylhexyl methoxycrylene, Behenyl Alcohol, Steareth-21, Glyceryl Stearate, PEG-100 Stearate, Calcium Sodium Borosilicate, Euphorbia Cerifera (Candelilla) Wax, Polyhydroxystearic Acid, Cetyl Alcohol, Triethoxycaprylylsilane, Aluminum Hydroxide, Xanthan Gum, Stearic Acid, Phenoxyethanol, Ethylhexylglycerin, Glycerin, Chlorphenesin, Tocopheryl Acetate, Disodium EDTA, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Extract

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 - 88 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno®

DERMATOLOGIST RECOMMENDED BRAND

SOOTHING OAT

Protect +

Soothe

MINERAL

SUNSCREEN

Broad Spectrum SPF 30

SENSITIVE SKIN

Naturally-sourced

100% mineral actives

Water resistant (80 minutes)

SPF

30

3.0 fl. OZ (88 mL)

AveenoAveeno

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-077169968-0771-1, 69968-0771-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
PEG-100 STEARATEYD01N1999RIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
OATZ6J799EAJKIACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT
CHLORPHENESINI670DAL4SZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CANDELILLA WAXWL0328HX19IACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
DOCOSANOL9G1OE216XYIACT
STEARETH-2153J3F32P58IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOHEXADECANE918X1OUF1EIACT

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
3b9e39cb-e987-580e-e063-6394a90abb84e49e3d23-2f9e-c69b-e053-2a95a90a68f72025-08-05WarningsExact identifier
spl id: 3b9e39cb-e987-580e-e063-6394a90abb84
spl set id: e49e3d23-2f9e-c69b-e053-2a95a90a68f7

Reported adverse events (FAERS/openFDA)#

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