Vacation Classic Whip SPF 30 Broad Spectrum Sunscreen Mousse

Vacation by

Drug Labeling and Warnings

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

Drug Details [pdf]

VACATION BROAD SPECTRUM SPF 30- homosalate, octisalate, octocrylene, avobenzone aerosol, foam 
Prime Packaging

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Vacation Classic Whip SPF 30 Broad Spectrum Sunscreen Mousse

Active Ingredients

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

Avobenzone 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see 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 store at temperatures above 120F
• Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do not use

on damaged or broken skin

Stop use and ask a doctor

if rash occurs

When using this product

Keep out of eyes. Rinse with water to remove.

Keep out of reach of children

In case of ingestion, get medical help or contact a Poison Control Center right away.

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 sized 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 am - 2 pm
• wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a physician

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Butyloctyl Salicylate, Carboxymethylcellulose Sodium, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Microcrystalline Cellulose, Musa Sapientum (Banana) Fruit Extract, Niacinamide (Vitamin B3), Phenoxyethanol, Polymethylsilsesquioxane, Polysorbate 20, Sodium Hyaluronate, Stearic Acid, Tapioca Starch, Tetrafluoropropene, Tetrasodium Glutamate Diacetate, Tocopheryl (Vitamin E) Acetate, VP/Hexadecene Copolymer, Water

Other Information

Product this product from excessive heat and direct sun

Vacation SPF 30 Mousse

VACATION  BROAD SPECTRUM SPF 30
homosalate, octisalate, octocrylene, avobenzone aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.05 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.075 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
BANANA (UNII: 4AJZ4765R9)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
STEARIC ACID (UNII: 4ELV7Z65AP)
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STARCH, TAPIOCA (UNII: 24SC3U704I)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0290-3	113 g in 1 CAN; Type 0: Not a Combination Product	08/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/26/2024

Labeler - Prime Packaging (805987059)

Registrant - Prime Packaging (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging		805987059	label(13630-0290) , pack(13630-0290)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	analysis(13630-0290) , manufacture(13630-0290)

Revised: 8/2024

Document Id: 209d6980-1d5e-8771-e063-6394a90a243f

34390-5

Set id: 209d6980-1d5d-8771-e063-6394a90a243f

Version: 1

Effective Time: 20240826