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Sunscreen 30 SPF

Dosage form: lotion
Ingredients: OCTINOXATE 22mL in 30mL, OXYBENZONE 16mL in 30mL
Labeler: Aztex Enterprises
NDC Code: 75887-003

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.

Drug Facts 30ml/1oz.
Active Ingredient Purpose
Octinoxate (7.3%) sunscreen
Oxybenzone (5.2%) sunscreen

Uses
Provides moderate protection against sunburn
For skin that burns easily

Warnings
For external use only.
When using this produce
Keep out of eyes, rinse with water to remove
Discontinue use of irritation and redness develop
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away
If pregnant or breastfeeding, ask a health care professional before use

Directions
Apply generously and evenly before sun exposure
Reapply as needed or after swimming or perspiring

Inactive Ingredients
Acrylate/C10-30 Alkylacrylate Crosspolymer
BHT
C12-15 Alkyl Benzoate
Carbomer polymers
Diazolydinyl Urea
Disodium EDTA
Hexyl Laurate
Methylparaben, Propylparaben
PEG-8, Sorbitan Oleate, Tocopheryl Acetate
Propylene Glycol, Triethanolamine, VP/Eicosene copolymer

AZX SPORT
30 SPF
Sunscreen
1 oz. / 30 ml.
Made in Canada
SUNSCREEN  30 SPF
octinoxate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75887-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE22 mL  in 30 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE16 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
BUTYLATED HYDROXYTOLUENE 
ALKYL (C12-15) BENZOATE 
CARBOMER 1342 
UREA 
EDETATE DISODIUM 
HEXYL LAURATE 
METHYLPARABEN 
PROPYLPARABEN 
POLYETHYLENE GLYCOL 400 
SORBITAN MONOOLEATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
PROPYLENE GLYCOL 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:75887-003-0130 mL in 1 BOTTLE
2NDC:75887-003-0260 mL in 1 BOTTLE
3NDC:75887-003-03118 mL in 1 BOTTLE
4NDC:75887-003-04236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/18/2011
Labeler - Aztex Enterprises (253232326)
Registrant - Aztex Enterprises (253232326)
Establishment
NameAddressID/FEIOperations
Aztex Enterprises253232326manufacture

Revised: 01/2011
Document Id: 1a05b791-a0ae-48b3-a951-b6928d0bfa44
Set id: 1bf464b3-f9ac-4c7e-9ec9-7a9b7e97f2e9
Version: 3
Effective Time: 20110118
 
Aztex Enterprises

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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