Label: VACATION SPF 50 SUPER SPRITZ FACE MIST- avobenzone, octisalate, octocrylene spray
- NDC Code(s): 80641-010-01, 80641-010-03
- Packager: Vacation Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 6, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VACATION SPF 50 SUPER SPRITZ FACE MIST
avobenzone, octisalate, octocrylene sprayProduct 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)