ATTITUDE  100% MINERAL SUNSCREEN - ORANGE BLOSSOM- zinc oxide cream 
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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ATTITUDE®
100% Mineral sunscreen - Orange Blossom

DRUG FACTS:

Active ingredient

Zinc oxide (20%)

Purpose

Sunscreen

Uses

-
Helps prevent sunburn
-
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only. Do not use on damaged or broken skin. If rash occurs, stop use and ask a doctor. When using this product keep 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

-
Apply liberally 15 minutes before sun exposure
-
Reapply:
-
At least every 2 hours
-
After 40 minutes of swimming or sweating
-
Immediately after towel drying
-
Ask a doctor for use on children under 6 months of age.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging

-
To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
-
Limit time in the sun, especially from 10am–2pm
-
Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive or non-medicinal ingredients

Aqua, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, glyceryl isostearate, glyceryl stearate, C10-18 triglycerides, glycerin, polyhydroxystearic acid, ethylhexylglycerin, caprylyl glycol, xanthan gum, sodium gluconate, pentadecalactone (fruit), linalyl acetate (floral), hexyl salicylate (floral).

Other Information

Store at temperatures below 90oF.

PRINCIPAL DISPLAY PANEL - 150 g Tube Label

BIO SPECTRA
ATTITUDE®

live consciously

30
SPF

100% MINERAL
SUNSCREEN

orange blossom • hypoallergenic

BROAD SPECTRUM (UVA/UVB), NON NANO

DERMATOLOGICALLY TESTED

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

WORRY-FREE
• INGREDIENTS •

NPN 80047088 • 150 g / 5.2 OZ.

PRINCIPAL DISPLAY PANEL - 150 g Tube Label
ATTITUDE   100% MINERAL SUNSCREEN - ORANGE BLOSSOM
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-012
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
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
PENTADECALACTONE (UNII: OK17S3S98K)  
LINALYL ACETATE (UNII: 5K47SSQ51G)  
HEXYL SALICYLATE (UNII: 8F78EY72YL)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61649-012-151 in 1 CARTON07/01/2014
1150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/2014
Labeler - Bio Spectra (201137051)

Revised: 7/2018
Document Id: fd2e93bd-8791-44b6-beef-e2dd8b969b27
Set id: 8f7ad01a-0a7f-44e8-9198-6764851e0318
Version: 1
Effective Time: 20180706
 
Bio Spectra