ALOE UP BROAD SPECTRUM SPF 30 SUNSCREEN- homosalate, octisalate, avobenzone, 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 SPORT PERFORMANCE SUNSCREEN Broad Spectrum SPF 30 Continuous Spray

INACTIVE INGREDIENTS

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

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 F.

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

Purpose

Sunscreen

Uses

Active Ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 2.75%

Homosalate 10%

Directions

Other Information

Questions or Comments?

Call toll free 1-800-950-2563 or visit www.aloeup.com

ALOE UP SPORT PERFORMANCE SUNSCREEN Broad spectrum SPF 30 - 5.5 oz (156 g)

Principle Display Label

ALOE UP  BROAD SPECTRUM SPF 30 SUNSCREEN
homosalate, octisalate, avobenzone, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0182
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ALCOHOL (UNII: 3K9958V90M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Product Characteristics
Coloryellow (Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0182-4156 g in 1 CANISTER; Type 0: Not a Combination Product09/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/28/2015
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028manufacture(13630-0182) , label(13630-0182) , pack(13630-0182) , analysis(13630-0182)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0182) , label(13630-0182)

Revised: 10/2021
Document Id: cf5a8d49-7929-56fd-e053-2995a90a0e65
Set id: cf5aaf75-8e3c-eafd-e053-2a95a90a2b25
Version: 1
Effective Time: 20211027
 
Prime Packaging Inc.