YERBA MATE MINERAL SPF 30 BROAD SPECTRUM- sunscreen spray 
Bell International Labroatories, Inc

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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Purity SPF 30 Yerba Mate Mineral Sunscreen Spray

Active Ingredient

Zinc Oxide 12%

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

Contents under pressure. Do not puncture or incinerate.

For external use only.

Do not spray directly on face

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

Do not spray directly onto face. Spray into hands and rub onto your face.

To ensure adequate sun protection, avoid spreading too thinly when applying

Shake well before use

Apply liberally 15 minutes before sun exposure

Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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 of 15 or higher and other sun protection measures including:

  • LImit time in the sun, especially from 10am-2pm
  • wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: Consult a physician.

Inactive Ingredients

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Jojoba Ester, Methyl Dihydroabietate, Water

Other Information

Protect this product from excessive heat and direct sunlight

PDP

PDP

YERBA MATE MINERAL  SPF 30 BROAD SPECTRUM
sunscreen spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCO GLUCOSIDE (UNII: ICS790225B)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BENTONITE (UNII: A3N5ZCN45C)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76150-211-2390 mL in 1 CAN; Type 0: Not a Combination Product08/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2015
Labeler - Bell International Labroatories, Inc (967781555)

Revised: 11/2017
 
Bell International Labroatories, Inc