BIO SPECTRA ATTITUDE- zinc oxide cream

BIO SPECTRA by

Drug Labeling and Warnings

BIO SPECTRA by is a Otc medication manufactured, distributed, or labeled by BIO SPECTRA, Les Entreprises Stefmar Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

Zinc oxide (20%)

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

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

Do not use on broken skin.

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

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and consult a doctor if rash occurs.

Directions

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

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

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

QUESTIONS

Questions ? 1-855-509-7225

PRINCIPAL DISPLAY PANEL - 75 g Tube Label

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.

INGREDIENTS AND APPEARANCE

BIO SPECTRA  ATTITUDE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM GLUCONATE (UNII: R6Q3791S76)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)

Product Characteristics
Color	white (Opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61649-120-01	75 g in 1 TUBE; Type 0: Not a Combination Product	12/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/18/2023

Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
9055-7588 Quebec Inc. DBA Attitude		204307099	manufacture(61649-120) , label(61649-120) , pack(61649-120) , analysis(61649-120)