FDA.reportPublic FDA data

ATTITUDE

Manufacturer
Bio Spectra | Federal Package Network Inc.
Effective date
2018-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:12

Label at a glance#

ProductATTITUDE Mineral Face SPF30 - Little Ones
Active ingredientZINC OXIDE
Label structure9 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: At least every 2 hours After 40 minutes of swimming or sweating Immediately after towel drying Ask a doctor for use on children under 6 months of age. 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 oth...

Storage and handling

Store at temperatures below 90°F.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide (20%)

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. If rash occurs, discontinue use.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

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:
    • At least every 2 hours
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
  • Ask a doctor for use on children under 6 months of age.
  • 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 10am–2pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive or non-medicinal ingredients

INACTIVE INGREDIENT SECTION

Olea europaea (olive) fruit oil, euphorbia cerifera (candelilla) wax, theobroma cacao (cocoa) seed butter, butyrospermum parkii (shea) butter, ricinus communis (castor) seed oil, cocos nucifera (coconut) oil, glyceryl stearate se, polyhydroxystearic acid.

Other Information

STORAGE AND HANDLING SECTION

Store at temperatures below 90°F.

PRINCIPAL DISPLAY PANEL - 18.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIO SPECTRA
ATTITUDE ®

little ones

30
SPF

100% MINERAL
FACE STICK

fragrance-free • hypoallergenic

BROAD SPECTRUM (UVA/UVB), NON NANO

DERMATOLOGICALLY TESTED

• EWG VERIFIED
FOR YOUR HEALTH •
EWG.ORG •™

WORRY-FREE
• INGREDIENTS •

NPN 80073697 • 18.4 g / 0.65 OZ.

PRINCIPAL DISPLAY PANEL - 18.4 g Tube Carton
PRINCIPAL DISPLAY PANEL - 18.4 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61649-013-182021-01-29C16284748780-1ba0f9c33-41c1-a910-e053-dadaa90a0b85ATTITUDE ® Mineral Face SPF30 - Little Ones

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-013-18ATTITUDE Mineral Face SPF30 - Little Ones18.4 g in 1 TUBE, WITH APPLICATORSTICK18.41
61649-013-18ATTITUDE Mineral Face SPF30 - Little Ones1 in 1 CARTONSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-013ATTITUDE MINERAL FACE SPF30 - LITTLE ONES (ZINC OXIDE) STICK [BIO SPECTRA]1Legacy NDC, 2 package rows20180709_523a616a-77ed-477c-9a3d-b1ab11ca803c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61649-01361649-013-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
OLIVE OIL6UYK2W1W1EIACT
CANDELILLA WAXWL0328HX19IACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
CASTOR OILD5340Y2I9GIACT
COCONUT OILQ9L0O73W7LIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
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
1a3393b2-f81f-4059-9e41-af76839a1e80523a616a-77ed-477c-9a3d-b1ab11ca803c2018-07-06WarningsExact identifier
spl id: 1a3393b2-f81f-4059-9e41-af76839a1e80
spl set id: 523a616a-77ed-477c-9a3d-b1ab11ca803c

Reported adverse events (FAERS/openFDA)#

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