SUMMER CAMP ENVIRO UV BROAD SPECTRUM SPF 50- octisalate, avobenzone, homosalate spray 
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.

----------

Summer Camp Enviro UV Sunscreen Mist Broad Spectrum SPF 50

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

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.

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

Other Information

Protect the product from excessive heat and direct sun.

INACTIVE INGREDIENTS

Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water​

Questions or Comments?

Call 800-217-8552

Summer Camp Enviro UV Facial Sunscreen Mist Broad spectrum SPF 50

Principle Display Label

SUMMER CAMP ENVIRO UV  BROAD SPECTRUM SPF 50
octisalate, avobenzone, homosalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0554
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE86 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LEVOMENOL (UNII: 24WE03BX2T)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ALCOHOL (UNII: 3K9958V90M)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (Very Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0554-350 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/08/2022
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0554) , manufacture(58443-0554) , label(58443-0554) , analysis(58443-0554)

Revised: 8/2022
Document Id: e65df0f4-667a-6711-e053-2995a90a7161
Set id: e65de9a6-2333-20db-e053-2995a90a83ce
Version: 1
Effective Time: 20220816
 
Prime Enterprises Inc.