BIO SPECTRA ATTITUDE ®

BIO SPECTRA by

Drug Labeling and Warnings

BIO SPECTRA by is a Otc medication manufactured, distributed, or labeled by BIO SPECTRA, Federal Package Network Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIO SPECTRA ATTITUDE- zinc oxide stick 
BIO SPECTRA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

Directions

  • Adults and children older than 6 months. Ask a doctor for use on children under 6 months of age.
  • Apply generously 15 minutes prior to sun exposure.
  • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing.
  • Use a water resistant sunscreen if swimming or sweating.

Inactive or non-medicinal ingredients

Olea europaea (olive) fruit oil, euphorbia cerifera (candelilla) wax, theobroma cacao (cocoa) seed butter, butyrospermum parkii (shea) butter, ricinus communis (castor) seed oil, cocos nucifera (coconut) oil, glyceryl stearate se, polyhydroxystearic acid.

Other Information

Store at temperatures below 90°F / 32°C. Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 18.4 g Tube Carton

ATTITUDE ®
bio spectra

natural care

KIDS
30
SPF

BROAD SPECTRUM SPF 30 (UVA/UVB)

mineral sunscreen
face stick
UNSCENTED

hypoallergenic

EWG VERIFIED
FOR YOUR HEALTH EWG.ORG™

ocean lovers

NPN 80073697
18.4 g / 0.65 oz.

PRINCIPAL DISPLAY PANEL - 18.4 g Tube Carton
BIO SPECTRA  ATTITUDE
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61649-900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL (UNII: 6UYK2W1W1E)  
CANDELILLA WAX (UNII: WL0328HX19)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SHEA BUTTER (UNII: K49155WL9Y)  
CASTOR OIL (UNII: D5340Y2I9G)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Product Characteristics
Colorwhite (Opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61649-900-211 in 1 CARTON05/13/202101/01/2023
1NDC: 61649-900-2018.4 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/13/202101/01/2023
Labeler - BIO SPECTRA (201137051)
Establishment
NameAddressID/FEIBusiness Operations
Federal Package Network Inc.118758804manufacture(61649-900)

Revised: 7/2023
Document Id: 00239ce6-f65a-be02-e063-6294a90a259f
Set id: 5e815d7e-95bf-41da-bcc3-d8b21470fe05
Version: 2
Effective Time: 20230710
 
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