FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:36

Label at a glance#

ProductAveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen 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 ensure complete coverage to the area above the lips, nose, and tops of ears. 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...

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

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
  • ensure complete coverage to the area above the lips, nose, and tops of ears.
  • 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 Neopentanoate, C12-15 Alkyl Benzoate, Synthetic Wax, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Avena Sativa (Oat) Kernel Oil, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol

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 - 13 g Canister Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno ®

NEW LOOK!

baby

continuous protection ®

sensitive skin

won’t run into the eyes and sting

mineral

sunscreen

stick

naturally-sourced

100% mineral

active ingredient

broad spectrum

UVA/UVB SPF 50

SPF

50

water resistant

(80 minutes)

NET WT

0.47 OZ. (13 g) AveenoAveeno

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0798-5Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 5013 g in 1 CANISTERSTICK132
69968-0798-5Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 501 in 1 BLISTER PACKSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0798AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) STICK [KENVUE BRANDS LLC]2Current NDC, 2 package rows20241107_f2fd12cf-45c0-163f-e053-2a95a90ad459.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-079869968-0798-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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

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
Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLCf2fd12cf-45c0-163f-e053-2a95a90ad4592024-11-05WarningsExact identifier
ndc (package): 69968-0798-5
ndc (product): 69968-0798
ndc11 (package): 69968079805
spl id: 21ad95bd-8843-bfd7-e063-6394a90a3143
spl set id: f2fd12cf-45c0-163f-e053-2a95a90ad459

Reported adverse events (FAERS/openFDA)#

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