FDA.reportPublic FDA data

ATTITUDE

Manufacturer
Bio Spectra | Fusion Solution inc
Effective date
2018-07-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:56:11

Label at a glance#

ProductATTITUDE Mineral sunscreen Sensitive Skin Care 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 sweathing - Immediately after towel drying - 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: - L...

Storage and handling

Store at temperatures below 90oF.

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. Do not use on damaged or broken skin. If rash occurs, stop use and ask a doctor. 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 sweathing - Immediately after towel drying - 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 - Ask a doctor for use on children under 6 months of age.

Inactive or non-medicinal ingredients

INACTIVE INGREDIENT SECTION

Aqua, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, avena sativa (oat) kernel flour, glyceryl isostearate, glyceryl stearate, C10-18 triglycerides, glycerin, polyhydroxystearic acid, ethylhexylglycerin, caprylyl glycol, xanthan gum, sodium gluconate.

Other Information

STORAGE AND HANDLING SECTION

Store at temperatures below 90oF.

PRINCIPAL DISPLAY PANEL - 75 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIO SPECTRA
ATTITUDE®
little ones

SENSITIVE SKIN CARE

WORRY-FREE
• INGREDIENTS •

SPF
30

100% MINERAL
SUNSCREEN
BROAD SPECTRUM (UVA/UVB), NON NANO

HYPOALLERGENIC • FRAGRANCE-FREE

ACCEPTED
NATIONALECZEMA.ORG

NATIONAL
Eczema
ASSOCIATION

NPN 80047088

75 g / 2.6 OZ.

PRINCIPAL DISPLAY PANEL - 75 g Tube Label
PRINCIPAL DISPLAY PANEL - 75 g Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61649-003-752021-01-29C16284748780-1ba0f9c33-37d1-a910-e053-dadaa90a0b85ATTITUDE ® Mineral sunscreen Sensitive Skin Care little ones

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-003-75ATTITUDE Mineral sunscreen Sensitive Skin Care little ones1 in 1 CARTONCREAM13
61649-003-75ATTITUDE Mineral sunscreen Sensitive Skin Care little ones75 g in 1 TUBECREAM753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-003ATTITUDE MINERAL SUNSCREEN SENSITIVE SKIN CARE LITTLE ONES (ZINC OXIDE) CREAM [BIO SPECTRA]3Legacy NDC, 2 package rows20180707_b1ac6959-577a-44e2-97b2-af37c2073c53.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61649-00361649-003-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
OATMEAL8PI54V663YIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
GLYCERINPDC6A3C0OXIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM GLUCONATER6Q3791S76IACT

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
af69eaaa-5394-445b-b921-741dc34cc0b2b1ac6959-577a-44e2-97b2-af37c2073c532018-07-03WarningsExact identifier
spl id: af69eaaa-5394-445b-b921-741dc34cc0b2
spl set id: b1ac6959-577a-44e2-97b2-af37c2073c53

Reported adverse events (FAERS/openFDA)#

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