VACATION SPF 50 SUPER SPRITZ FACE MIST- avobenzone, octisalate, octocrylene spray

Vacation SPF 50 Super Spritz Face Mist by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone (2.9%)

Homosalate (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

Flammable. Do not spray near heat, sparks, sources of ignition, or flames.
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

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

Directions

Hold spray 8-10 inches from face with eyes and mouth closed before using

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

Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Caffeine, Camellia Sinensis (Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chlorella Vulgaris Extract, Cocos Nucifera (Coconut) Extract, Cucumis Sativus (Cucumber) Seed Oil, Diisooctyl Succinate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Fragrance, Musa Sapientum (Banana) Fruit Extract, Passiflora Edulis Seed Oil, Polyester-8, Tocopherol (Vitamin E), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VACATION SPF 50 SUPER SPRITZ FACE MIST 
avobenzone, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-010
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUCCINIC ACID (UNII: AB6MNQ6J6L)
ETHYL FERULATE (UNII: 5B8915UELW)
VINYL ACETATE (UNII: L9MK238N77)
WATER (UNII: 059QF0KO0R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SHEANUT OIL (UNII: O88E196QRF)
CAFFEINE (UNII: 3G6A5W338E)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CUCUMBER SEED OIL (UNII: AKP926H71P)
COCONUT (UNII: 3RT3536DHY)
TOCOPHEROL (UNII: R0ZB2556P8)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BANANA (UNII: 4AJZ4765R9)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-010-01	65 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2023
2	NDC: 80641-010-03	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2023

Labeler - Vacation Inc. (117644631)