CARNIVAL ADVENTURES SPORT SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate 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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Carnival Adventures 50 Sport Continuous Spray Sunscreen Broad Spectrum SPF 50

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

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.

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. Contents under pressure- do not puncture or incinerate. Do not store at temperatures above 120 0F

Directions

Inactive ingredients

Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

Question or comments?

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Carnival Adventures 50 Sport Continuous Spray Sunscreen Broad Spectrum SPF 50

Principle Display Label

CARNIVAL ADVENTURES  SPORT SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE42 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.2 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE84 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE42 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
VINYL ACETATE (UNII: L9MK238N77)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
Coloryellow (Light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0280-4186 mL in 1 CAN; Type 0: Not a Combination Product03/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02003/29/2022
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0280) , analysis(13630-0280)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0280) , label(13630-0280)

Revised: 9/2023
Document Id: 04c79ee8-132a-7010-e063-6294a90a8560
Set id: 04c7d17e-28c3-c74b-e063-6394a90a8f31
Version: 1
Effective Time: 20230907
 
Prime Packaging Inc.