VACATION BY VACATION SCENT AND SHIMMER DUO- avobenzone, homosalate, octisalate, and octocrylene kit

Vacation by Vacation Scent and Shimmer Duo by

Drug Labeling and Warnings

Vacation by Vacation Scent and Shimmer Duo by is a Otc medication manufactured, distributed, or labeled by Vacation Inc., Bell International, Oxygen. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (2.9%), Homosalate (5.0%), Octisalate (4.9%), Octocrylene (8.0%)

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.

• Do not use on damaged or broken skin.

• When using this product, keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• 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.
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating.
• 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
• Children under 6 months of age: ask a physician.

Inactive ingredients

Argania Spinosa (Argan) Kernel Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Hyaluronic Acid, Iron Oxides, Mica, Musa Sapientum (Banana) Fruit Extract, Neopentyl Glycol Diethylhexanoate, Palmitoyl Tripeptide-1, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer

Other information

• Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed by Vacation Inc.
936 SW 1st Ave #888 Miami, FL 33130

PRINCIPAL DISPLAY PANEL - Kit Carton

"VACATION" by Vacation®

SCENT & SHIMMER DUO

1.7 FL OZ (50 ML) EAU DE TOILETTE + 2.9 FL OZ (86 ML) SHIMMER OIL SPF 30

INGREDIENTS AND APPEARANCE

VACATION BY VACATION SCENT AND SHIMMER DUO 
avobenzone, homosalate, octisalate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-203

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-203-01	1 in 1 CARTON	05/15/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	86 mL
Part 2	1 BOTTLE	50 mL

Part 1 of 2

SHIMMER OIL 
avobenzone homosalate octisalate octocrylene oil

Product Information
Item Code (Source)	NDC: 80641-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2.9 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	5 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4.9 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEANUT OIL (UNII: O88E196QRF)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYL FERULATE (UNII: 5B8915UELW)
HYALURONIC ACID (UNII: S270N0TRQY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
BANANA (UNII: 4AJZ4765R9)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
JOJOBA OIL (UNII: 724GKU717M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-015-15	86 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/15/2024

Part 2 of 2

VACATION BY VACATION EDT 50ML 
colognes and toilet waters [fragrance preparations]

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		05/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/15/2024

Labeler - Vacation Inc. (117644631)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International		967781555	MANUFACTURE(80641-203)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen		137098492	MANUFACTURE(80641-203)