BIO SPECTRA

Manufacturer
BIO SPECTRA | Les Entreprises Stefmar Inc.
Effective date
2020-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:05:43

Label at a glance#

ProductBIO SPECTRA ATTITUDE
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Adults and children older than 6 months. Apply generously 15 minutes prior to sun exposure. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing.

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.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin. If rash occurs, stop use and ask a doctor.

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. Ask a doctor for use on children under 6 months of age.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children older than 6 months.

  • Apply generously 15 minutes prior to sun exposure.
  • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing.

Inactive or non-medicinal ingredients

INACTIVE INGREDIENT SECTION

Aqua / water / eau, caprylic / capric triglyceride, cetearyl alcohol, glyceryl stearate, cetearyl glucoside, glyceryl isostearate, ethylhexylglycerin, glycerin, C10-18 triglycerides, polyhydroxystearic acid, behenyl alcohol, sodium chloride, xanthan gum, caprylyl glycol, sodium gluconate, geranyl acetate (herbal), vanillin, methyldihydrojasmonate (jasmine).

Other Information

STORAGE AND HANDLING SECTION

Store at temperatures below 90°F.

PRINCIPAL DISPLAY PANEL - 150 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bio spectra

ATTITUDE®

natural care

KIDS
30
SPF

BROAD SPECTRUM (UVA/UVB), NON NANO

mineral sunscreen

VANILLA BLOSSOM

hypoallergenic

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

ocean lovers

NPN 80047088 • 150 g / 5.2 OZ.

PRINCIPAL DISPLAY PANEL - 150 g Tube Label
PRINCIPAL DISPLAY PANEL - 150 g Tube Label

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61649-13061649-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
0e848f2d-ba0f-b854-e063-6394a90a815361e8d984-bb77-41ca-aac2-a1b0d7f56c4d2024-01-09WarningsExact identifier
spl set id: 61e8d984-bb77-41ca-aac2-a1b0d7f56c4d

Reported adverse events (FAERS/openFDA)#

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