SUNTONE BROAD SPECTRUM SPF 4- avobenzone, octocrylene lotion 
Prime Enterprises, 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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Active ingredients

Avobenzone 1 %, Octocrylene 0.85 %

Purpose

Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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.

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.

Directions

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other information

Questions or Comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL 33014

PRINCIPAL DISPLAY PANEL - 177 mL  Can Label

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Suntone

Fit for the sun

Sunscreen Lotion

Broad Spectrum SPF 4

Water Resistant (80 minutes)

Non-Greasy Formula

4

6 FL. OZ /177mL

SUNTONE  BROAD SPECTRUM SPF 4
avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE9.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0100-4177 mL in 1 CAN; Type 0: Not a Combination Product02/04/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/04/2013
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0100) , pack(58443-0100) , manufacture(58443-0100) , analysis(58443-0100)

Revised: 1/2020
Document Id: 9c5a9eec-5956-e6c2-e053-2995a90af80e
Set id: 245edcdc-4414-43f7-bf83-e16fc3310f3a
Version: 4
Effective Time: 20200117
 
Prime Enterprises, Inc.