VACATION WORLD CLASSIC WHIP SPF 30- dimethicone 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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Vacation World Classic Whip Broad Spectrum SPF 30

Active Ingredients

Homosalate 7.5%, Octisalate 5%, Octocrylene 5%, Avobenzone 3%

Purpose

Sunscreen

Uses

Warnings

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs

When using this product

  • Keep out fo eyes. Rinse with water to remove.
  • Do not store at temperatures above 120 F.

  • Keep out of reach of children. In case of ingestiion, get medical help or contact a Poison Control Center right away.

Use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Microcrystalline Cellulose, Musa Sapientum (Banana) Fruit Extract, Niacinamide, PVP/Hexadecene Copolymer, Phenoxyethanol, Polymethylsilsesquioxane, Polysorbate 20, Sodium Hyaluronate, Stearic Acid, Tapioca Starch, Tetrafluoropropene, Tetrasodium Glutamate Diacetate , Tocopheryl Acetate, Water

Other information

Vacation World Classic Whip Broad Spectrum SPF 30 Sunscreen Mousse

Principle Display Label

VACATION WORLD  CLASSIC WHIP SPF 30
dimethicone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0232
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE50.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BANANA (UNII: 4AJZ4765R9)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
Colorwhite (Off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0232-3112 mL in 1 CAN; Type 0: Not a Combination Product04/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/08/2022
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028analysis(13630-0232) , manufacture(13630-0232)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0232) , label(13630-0232)

Revised: 4/2022
Document Id: dc26c38b-dd62-3217-e053-2995a90a2b14
Set id: dc26ab5b-f23f-5566-e053-2995a90a21cb
Version: 1
Effective Time: 20220408
 
Prime Packaging Inc.