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

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 Ingredients

Avobenzone 2.9%

Homosalate 8.8%

Octisalate 4.9%

Octocrylene 7.6%

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

Flammable. Do not spray near heat, sparks, or sources of ignition (or flames). 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 of eyes. Rinse with water to remove.

-Do not store at temperatures above 120 F

-Do not spray product directly on face. Spay onto hands and rub into face. Do not inhale spray.

Keep out of reach of children. If swallowed, 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 Measure: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

-Limit time in the sun, especially from 10 a.m. to 2 p.m.
-Wear long-sleeved shirts, pants, hats, and sun glasses.

Children under 6 months: ask a doctor.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Extract, Diisopropyl Adipate, Ethylhexyl Methoxycrylene, Fragrance, Musa Sapientum (Banana) Fruit Extract, Polyester-8, Tocopherol (Vitamin E)

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 spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8.8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BANANA (UNII: 4AJZ4765R9)
TOCOPHEROL (UNII: R0ZB2556P8)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEANUT OIL (UNII: O88E196QRF)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCONUT (UNII: 3RT3536DHY)
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-007-01	177 mL in 1 CAN; Type 0: Not a Combination Product	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2022

Labeler - Vacation Inc. (117644631)