FDA.reportPublic FDA data

Aveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 50

Manufacturer
Kenvue Brands LLC
Effective date
2025-05-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:37:31

Label at a glance#

ProductAveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientZINC 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 generously 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 th...

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics package contains small parts, which could cause a choking hazard

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Zinc Oxide (21.6%)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

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 generously 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
  • package contains small parts, which could cause a choking hazard

Inactive ingredients

INACTIVE INGREDIENT SECTION

Octyldodecyl Neopentonate,C12-15 Alkyl Benzoate, Synthetic wax, Paraffin ,Silica, Neopentyl glycol, Diethylhexonate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer ,Trihexocarpylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil, 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 - 42g Canister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

Aveeno®

Protect +

Soothe

MINERAL

SUNSCREEN STICK

Broad Spectrum SPF 50

SENSITIVE SKIN

Water resistant (80 min)

SPF

50

net wt.1.5 OZ

(42 g)

AveenoAveeno

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-078069968-0780-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
NEOPENTYL GLYCOL DIISOSTEARATE4M6OQ34JWWIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PARAFFINI9O0E3H2ZEIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CERESINQ1LS2UJO3AIACT
OAT KERNEL OIL3UVP41R77RIACT

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
362d8e53-e17f-d7a0-e063-6294a90abe2dea1eac5c-3251-6277-e053-2a95a90a5fba2025-05-28WarningsExact identifier
spl id: 362d8e53-e17f-d7a0-e063-6294a90abe2d
spl set id: ea1eac5c-3251-6277-e053-2a95a90a5fba

Reported adverse events (FAERS/openFDA)#

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