FDA.reportPublic FDA data

BIO SPECTRA

Manufacturer
9055-7588 Quebec Inc. DBA Attitude
Effective date
2024-12-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:37:49

Label at a glance#

ProductBIO SPECTRA ATTITUDE
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Adults and children older than 6 months. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and...

Storage and handling

Store at temperatures below 90°F and protect from direct sun.

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.

Warnings

WARNINGS SECTION

Allergens: soybeans (glycerin). For external use only.

OTC - DO NOT USE SECTION

Do not use on broken skin.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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.

OTC - STOP USE SECTION

Stop use and consult a doctor if rash occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children older than 6 months.

  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor.

Inactive or non-medicinal ingredients

INACTIVE INGREDIENT SECTION

Aqua / Water / Eau, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Glyceryl Stearate, Cetearyl Alcohol, Polyhydroxystearic Acid, C10-18 Triglycerides, Glycerin, Ethylhexylglycerin, Caprylyl Glycol, Behenyl Alcohol, Sodium Chloride, Xanthan Gum, Sodium Gluconate.

Other Information

STORAGE AND HANDLING SECTION

Store at temperatures below 90°F and protect from direct sun.

RECENT MAJOR CHANGES SECTION

Dosage and administration : update of the Directions

OTC - QUESTIONS SECTION

Questions ? 1-855-509-7225

PRINCIPAL DISPLAY PANEL - 150 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATTITUDE ®
natural care

SPF 30

Unscented

Mineral sunscreen

Broad spectrum SPF 30

UVA/UVB - Non nano

SUNLY

VEGAN

Dermatologically tested

EWG Verified

NPN 80047088 • 150 g e / 5.2 OZ.

LabelLabel

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-110-15BIO SPECTRAATTITUDE150 g in 1 TUBECREAM1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-110BIO SPECTRA ATTITUDE (ZINC OXIDE) CREAM [9055-7588 QUEBEC INC. DBA ATTITUDE]5Current NDC, Legacy NDC, 1 package rows20241120_954713fe-c84c-41b4-913d-3507ed91e55d.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
61649-11061649-110-15

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
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
DOCOSANOL9G1OE216XYIACT
SODIUM CHLORIDE451W47IQ8XIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM GLUCONATER6Q3791S76IACT
ZINC OXIDESOI2LOH54ZACTIB

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
BIO SPECTRA ATTITUDEZINC OXIDE9055-7588 Quebec Inc. DBA Attitude954713fe-c84c-41b4-913d-3507ed91e55d2024-12-01WarningsExact identifier
ndc (package): 61649-110-15
ndc (product): 61649-110
ndc11 (package): 61649011015
spl id: 273701b7-3462-bd2d-e063-6294a90a1a94
spl set id: 954713fe-c84c-41b4-913d-3507ed91e55d

Reported adverse events (FAERS/openFDA)#

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