Vacation World Classic Whip Broad Spectrum SPF 30

Vacation World by

Drug Labeling and Warnings

Vacation World by is a Otc medication manufactured, distributed, or labeled by Prime Packaging Inc., Prime Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Helps prevent sunburn
• If used as directed with other sun protection measures (Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only
• Contents under pressure. Do not puncture or incinerate can.

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

• Apply liberally 15 minutes before sun exposure. Dispense a ping pong ball size amount and apply to a single area (arm,leg,chest,or back). Repeat up to 4 times (roughly a tennis ball size amount) for a whole body application.
• Do not spray product directly on face. Spray onto hands and rub onto face.
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including
• limit time in the sun, especially from 10 a.m.- 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• Chidlren under 6 months of age: ask a physician

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

• Protect this product from excessive heat and direct sun

Vacation World Classic Whip Broad Spectrum SPF 30 Sunscreen Mousse

VACATION WORLD  CLASSIC WHIP SPF 30
dimethicone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	75.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	50.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0232-3	112 mL in 1 CAN; Type 0: Not a Combination Product	04/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/08/2022

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	analysis(13630-0232) , manufacture(13630-0232)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0232) , label(13630-0232)

Revised: 4/2022

Document Id: dc26c38b-dd62-3217-e053-2995a90a2b14

34390-5

Set id: dc26ab5b-f23f-5566-e053-2995a90a21cb

Version: 1

Effective Time: 20220408