ALOE UP BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate and 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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ALOE UP BROAD SPECTRUM SPF 50

Aloe Up Lil' Kids SPF 50 Continuous Spray Sunscreen

Principle Label Panel

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Sunscreen

Uses

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 - not puncture or incinerate. Do not store at temperatures above 120°F

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

Directions

Aloe Barbadensis Extract, Cocos Nucifera (Coconut) Oil, Diethylhexyl 2,6-Napthalate, Mineral Oil (Paraffinum Liquidum), Polyester-8, SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

Questions or Comments?

Call toll free 1-800-950-2563

ALOE UP  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE24.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE83 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
MINERAL OIL (UNII: T5L8T28FGP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0095-4177 mL in 1 CAN; Type 0: Not a Combination Product07/27/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/27/2015
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.805987059pack(13630-0095) , manufacture(13630-0095) , label(13630-0095)

Revised: 9/2015
Document Id: 205c42c1-6830-4e70-e054-00144ff88e88
Set id: 205c42c1-682f-4e70-e054-00144ff88e88
Version: 1
Effective Time: 20150922
 
Prime Packaging Inc.