Label: VACATION WORLD CLASSIC WHIP SPF 30- dimethicone spray
- NDC Code(s): 13630-0232-3
- Packager: Prime Packaging Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 8, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
- For external use only
- Contents under pressure. Do not puncture or incinerate can.
When using this product
- Keep out fo eyes. Rinse with water to remove.
- Do not store at temperatures above 120 F.
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Directions
- Apply liberally 15 minutes before sun exposure. Dispense a ping pong ball size amount and apply to a single area (arm,leg,chest,or back). Repeat up to 4 times (roughly a tennis ball size amount) for a whole body application.
- Do not spray product directly on face. Spray onto hands and rub onto face.
- 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
- Chidlren under 6 months of age: ask a physician
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Inactive Ingredients
Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Microcrystalline Cellulose, Musa Sapientum (Banana) Fruit Extract, Niacinamide, PVP/Hexadecene Copolymer, Phenoxyethanol, Polymethylsilsesquioxane, Polysorbate 20, Sodium Hyaluronate, Stearic Acid, Tapioca Starch, Tetrafluoropropene, Tetrasodium Glutamate Diacetate , Tocopheryl Acetate, Water
- Other information
- Vacation World Classic Whip Broad Spectrum SPF 30 Sunscreen Mousse
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INGREDIENTS AND APPEARANCE
VACATION WORLD CLASSIC WHIP SPF 30
dimethicone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 75.8 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50.5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 50.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 20 (UNII: 7T1F30V5YH) NIACINAMIDE (UNII: 25X51I8RD4) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) STARCH, TAPIOCA (UNII: 24SC3U704I) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BANANA (UNII: 4AJZ4765R9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) Product Characteristics Color white (Off-White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0232-3 112 mL in 1 CAN; Type 0: Not a Combination Product 04/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/08/2022 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 analysis(13630-0232) , manufacture(13630-0232) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0232) , label(13630-0232)
