SUNTONE SUNSCREEN BROAD SPECTRUM SPF70- avobenzone, homosalate, octisalate, octocrylene spray 
Prime Packaging, 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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Suntone Sport Sunscreen Continuous Spray Broad Spectrum SPF 70

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120ºF.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable:Do not use near heat, flame or while smoking.

Directions

Inactive ingredients

Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other information

• protect this product from excessive heat and direct sun

• avoid spraying on fabrics - could cause discoloration.

Questions or comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL 33014

Suntone Sport Sunscreen Continuous Spray Broad Spectrum SPF 70

Principle Display Label

SUNTONE  SUNSCREEN BROAD SPECTRUM SPF70
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE87 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE130.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
ALCOHOL (UNII: 3K9958V90M)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
Product Characteristics
Coloryellow (Colorless to light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0220-4185 mL in 1 CAN; Type 0: Not a Combination Product01/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/18/2022
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0220) , analysis(13630-0220)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0220) , pack(13630-0220)

Revised: 1/2022
Document Id: d608b22e-b4e0-59af-e053-2a95a90a3045
Set id: d608a8d3-1305-a7b3-e053-2a95a90acd6c
Version: 1
Effective Time: 20220120
 
Prime Packaging, Inc.