FDA.reportPublic FDA data

BIO SPECTRA

Manufacturer
9055-7588 Quebec Inc. DBA Attitude
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:40:14

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, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil.

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 - 75 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATTITUDE ®

SPF 30

Unscented

SUNLY
Mineral Face Sunscreen

BROAD SPECTRUM SPF 30

UVA/UVB, NON NANO

Vegan

Dermatologically tested

EWG Verified

NPN 80047088 • 75 g / 2.6 OZ.

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-120-01BIO SPECTRAATTITUDE75 g in 1 TUBECREAM755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-120BIO SPECTRA ATTITUDE (ZINC OXIDE) CREAM [9055-7588 QUEBEC INC. DBA ATTITUDE]5Current NDC, Legacy NDC, 1 package rows20241205_06245c8c-93e8-4ebb-bab0-3db64dc178b9.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61649-12061649-120-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
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 Attitude06245c8c-93e8-4ebb-bab0-3db64dc178b92024-12-09WarningsExact identifier
ndc (package): 61649-120-01
ndc (product): 61649-120
ndc11 (package): 61649012001
spl id: 284c909f-5430-3b84-e063-6394a90a1c08
spl set id: 06245c8c-93e8-4ebb-bab0-3db64dc178b9

Reported adverse events (FAERS/openFDA)#

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