VACATION SPF 50 CLASSIC- avobenzone, homosalate, octisalate, octocrylene lotion

Vacation SPF 50 Classic by

Drug Labeling and Warnings

Vacation SPF 50 Classic by is a Otc medication manufactured, distributed, or labeled by Vacation Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone (2.%), Homosalate (9.8%), Octisalate (4.9%), Octocrylene (9.5%)

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
• Do not use on damaged or broken skin
• When using this product, keep out of eyes. Rinse with water to remove.
• Stop useand ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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: 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
• Children under 6 months of age: ask a physician.

INACTIVE INGREDIENT

Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Musa Paradisiaca (Banana) Fruit Extract, Niacinamide, Phenoxyethanol, Silica, Sodium Hyaluronate, Sodium Phytate, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Water

Other Information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VACATION SPF 50 CLASSIC 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BANANA (UNII: 4AJZ4765R9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHYTATE SODIUM (UNII: 88496G1ERL)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-006-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2022
2	NDC: 80641-006-80	30 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2022

Labeler - Vacation Inc. (117644631)