FDA.reportPublic FDA data

Titanium Dioxide and Zinc Oxide

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-05-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:31:52

Label at a glance#

ProductAveeno Baby continuous Protection sensitive skin sunscreen Face Broad Spectrum SPF50
Active ingredientTitanium Dioxide, Zinc 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 lip, 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (8.1%), Zinc Oxide (6.8%)

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 lip, 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Dimethicone, Paraffin, Ozokerite, Beeswax, Phenyl Trimethicone, Euphorbia Cerifera (Candelilla) Wax, Polyethylene, Polyhydroxystearic Acid, Dipropylene Glycol Dibenzoate, Triethoxycaprylylsilane, PPG-15 Stearyl Ether Benzoate, Caprylyl Glycol, Ethylhexylglycerin, Avena Sativa (Oat) Kernel Flour, BHT

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 - 14 g Cylinder Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEDIATRICIAN RECOMMENDED BRAND
Aveeno
Baby®

CONTINUOUS
PROTECTION®
sensitive skin
sunscreen
face stick
BROAD SPECTRUM
SPF 50
naturally-sourced
100%
mineral active
ingredients
great for on-the-go
sweat + water
resistant (80 min)
SPF
50

net wt. 0.5 oz (14 g)

Principal Display Panel - 14 g Cylinder Blister Pack
Principal Display Panel - 14 g Cylinder Blister Pack

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-044769968-0447-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Octyldodecyl NeopentanoateX8725R883TIACT
Dimethicone92RU3N3Y1OIACT
ParaffinI9O0E3H2ZEIACT
Yellow Wax2ZA36H0S2VIACT
Phenyl TrimethiconeDR0K5NOJ4RIACT
Candelilla WaxWL0328HX19IACT
High Density PolyethyleneUG00KM4WR7IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
Dipropylene Glycol Dibenzoate6OA5ZDY41OIACT
TriethoxycaprylylsilaneLDC331P08EIACT
PPG-15 Stearyl Ether Benzoate80D2J6361MIACT
Caprylyl Glycol00YIU5438UIACT
Ethylhexylglycerin147D247K3PIACT
OatZ6J799EAJKIACT
Butylated Hydroxytoluene1P9D0Z171KIACT

Source Document#

Source XML · Source PDF

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
ed616ad7-01e0-447a-b71c-52ecbcaffa087e643b33-11dc-4245-9368-729b4ff2f92b2020-05-07WarningsExact identifier
spl id: ed616ad7-01e0-447a-b71c-52ecbcaffa08
spl set id: 7e643b33-11dc-4245-9368-729b4ff2f92b

Reported adverse events (FAERS/openFDA)#

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