BIO SPECTRA ATTITUDE ®

Drug Details [pdf]

BIO SPECTRA ATTITUDE- zinc oxide cream
BIO SPECTRA

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BIO SPECTRA
ATTITUDE ®

DRUG FACTS

Active ingredient

Zinc oxide (20%)

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

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

When using this productkeep out of eyes. Rinse with water to remove.

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

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

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

Store at temperatures below 90°F.

PRINCIPAL DISPLAY PANEL - 150 g Tube Label

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

BIO SPECTRA ATTITUDE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-130
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM GLUCONATE (UNII: R6Q3791S76)
GERANYL ACETATE (UNII: 3W81YG7P9R)
VANILLIN (UNII: CHI530446X)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 61649-130-01	150 g in 1 TUBE; Type 0: Not a Combination Product	11/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/25/2020	01/31/2023

Labeler - BIO SPECTRA (201137051)

Name	Address	ID/FEI	Business Operations
Establishment
Les Entreprises Stefmar Inc.		240496385	manufacture(61649-130)

Revised: 1/2024

Document Id: 0e848f2d-ba0f-b854-e063-6394a90a8153

Set id: 61e8d984-bb77-41ca-aac2-a1b0d7f56c4d

Version: 2

Effective Time: 20240109