SOLMATE BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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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Active ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

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 120 0F

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, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylphthalimide, Chamomilla Recutita (Matricaria) Flower Extract, Disodium EDTA, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sorbitol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water

Other information

Questions or Comments? Biocycle Laboratories, Inc.

16363 NW 49th Avenue, Miami, FL 33014

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

PRINCIPAL DISPLAY PANEL - 177 mL Can Label


SOL

MATE

BABY

CONTINUOUS SPRAY

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

6 FL. OZ. / 177 mL

SOLMATE  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.1 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.6 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CHAMOMILE (UNII: FGL3685T2X)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITOL (UNII: 506T60A25R)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0060-4177 mL in 1 CAN; Type 0: Not a Combination Product04/16/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/16/2012
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0060) , analysis(13630-0060)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0060) , pack(13630-0060)

Revised: 1/2020
Document Id: 9c5cb056-3de2-7272-e053-2995a90a3284
Set id: acb1e9cd-3c98-4ff8-9ea0-94b1288d0fd3
Version: 3
Effective Time: 20200117
 
Prime Packaging, Inc.