VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene lotion

VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN by

Drug Labeling and Warnings

VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Vacation Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (2.5%), Homosalate (10%), Octisalate (5%), Octocrylene (8%)

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:
  • 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 ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Cocoate, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Musa Sapientum (Banana) Fruit Extract, Niacinamide (Vitamin B3), Phenoxyethanol, Polyurethane-35, Silica, Sodium Hyaluronate, Sodium Phytate, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Tocopheryl (Vitamin E) Acetate, Water

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 - 100 ML Tube Label

Vacation®

Classic Lotion
BROAD SPECTRUM SPF 30 SUNSCREEN

By the "Legendary" Vacation® of Miami—
"Leisure-Enhancing" & "Excessively Good"
Sunscreen for "Long Days by the Pool"
Water-Resistant (80 Minutes)
"The Scent of Summer"

SPF 30

3.4 FL OZ / 100 ML

INGREDIENTS AND APPEARANCE

VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	25 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Shea Butter (UNII: K49155WL9Y)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Coconut Oil (UNII: Q9L0O73W7L)
Dimethicone (UNII: 92RU3N3Y1O)
Ethylhexyl Cocoate (UNII: I1MPW273QS)
Ethylhexyl Palmitate (UNII: 2865993309)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Banana (UNII: 4AJZ4765R9)
Niacin (UNII: 2679MF687A)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Phytate Sodium (UNII: 88496G1ERL)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-001-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/15/2021
2	NDC: 80641-001-02	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/06/2022
3	NDC: 80641-001-03	7 mL in 1 PACKET; Type 0: Not a Combination Product	04/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	04/15/2021

Labeler - Vacation Inc. (117644631)