FDA.reportPublic FDA data

Aveeno Protect Plus Soothe Face Mineral Sunscreen SPF 30

Manufacturer
Kenvue Brands LLC
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:00

Label at a glance#

ProductAveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30
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

For sunscreen use: ▪ Apply generously and evenly 15 minutes before sun exposure ▪ Reapply at least every 2 hours ▪ Use a water resistant sunscreen if swimming or sweating ▪ 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 includ...

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

Titanium Dioxide

Zinc Oxide

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide (5.8%)Sunscreen
Zinc Oxide (12.5%)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

  • 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

For sunscreen use:

▪ Apply generously and evenly 15 minutes before sun exposure

▪ Reapply at least every 2 hours

▪ Use a water resistant sunscreen if swimming or sweating

▪ 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, Caprylic/Capric Triglyceride, Glycerin, Ethylhexyl,Methoxycrylene, Dimethicone, Triacontanyl PVP, Glyceryl Stearate, Calcium Sodium Borosilicate, PEG-100 Stearate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Avena Sativa (Oat) Kernel Extract, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Tocopheryl Acetate, Xanthan Gum, Cetearyl Olivate, Sorbitan Olivate, Stearic Acid,Triethoxycaprylylsilane, Ethylhexylglycerin, Sodium Chloride, Phenoxyethanol, Cetearyl Alcohol, Chlorphenesin, Disodium EDTA, Aluminum Hydroxide, Iron Oxides

Questions?

OTC - QUESTIONS SECTION

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 48mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​ NEW

Aveeno ®

Calm +

Restore

DAILY

MOISTURIZER

mineral sunscreen

BROAD SPECTURM

SPF 30

ZINC OXIDE

TITANIUM DIOXIDE

Sensitive Skin

Lightweight

all day moisture

FRAGRANCE FREE

SPF

30

DERMATOLOGIST RECOMMENDED BRAND

SOOTHING OAT+ FEVERFEW

1.7 FL OZ (48 mL)

Aveeno_1Aveeno_1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0813-1Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 3014 mL in 1 TUBELOTION143
69968-0813-1Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 3012 in 1 TRAYLOTION123
69968-0813-2Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION13
69968-0813-2Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 3048 mL in 1 TUBELOTION483

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-081369968-0813-2, 69968-0813-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN OLIVATEMDL271E3GRIACT
FERROUS OXIDEG7036X8B5HIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
TANACETUM PARTHENIUM6GE7Z0761KIACT
CETEARYL OLIVATE58B69Q84JOIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM CHLORIDE451W47IQ8XIACT
CHLORPHENESINI670DAL4SZIACT
TRIACONTANYL PVP (WP-660)N0SS3Q238DIACT
OATZ6J799EAJKIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
XANTHAN GUMTTV12P4NEEIACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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 Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
ndc (package): 69968-0813-1
ndc (package): 69968-0813-2
ndc (product): 69968-0813
ndc11 (package): 69968081302
ndc11 (package): 69968081301
spl id: 36bdd00b-3fe3-2268-e063-6294a90af4fd
spl set id: fbf8be03-93e2-4d7e-e053-6294a90a4fd5

Reported adverse events (FAERS/openFDA)#

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