Label: VACATION LIP TRIPS DESSERTS PINEAPPLE UPSIDE DOWN CAKE- avobenzone, homosalate, octisalate, and octocrylene stick
VACATION LIP TRIPS DESSERTS BOMBE ALASKA- avobenzone, homosalate, octisalate, and octocrylene stick
VACATION LIP TRIPS DESSERTS AFTER DINNER MINT- avobenzone, homosalate, octisalate, and octocrylene stick
VACATION LIP TRIPS DESSERTS STRAWBERRY JELLO- avobenzone, homosalate, octisalate, and octocrylene stick
VACATION LIP TRIPS DESSERTS BANANAS FOSTER- avobenzone, homosalate, octisalate, and octocrylene stick
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Contains inactivated NDC Code(s)
NDC Code(s): 80641-100-01, 80641-101-01, 80641-102-01, 80641-103-01, view more80641-104-01 - Packager: Vacation 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 January 5, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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.
- Other information
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Inactive ingredients
Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyloctyl Salicylate, C18-38 Alkyl Hydroxystearoyl Stearate, Canola Oil, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Wax, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Stevia Rebaudiana Leaf Extract, Sunflower Seed Oil Glycerides, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Tocopheryl Acetate
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - PINEAPPLE UPSIDE-DOWN CAKE
- PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - BOMBE ALASKA
- PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - AFTER DINNER MINT
- PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - STRAWBERRY JELLO SALAD
- PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - BANANAS FOSTER
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INGREDIENTS AND APPEARANCE
VACATION LIP TRIPS DESSERTS PINEAPPLE UPSIDE DOWN CAKE
avobenzone, homosalate, octisalate, and octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.03 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Butyloctyl Salicylate (UNII: 2EH13UN8D3) C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM) Canola Oil (UNII: 331KBJ17RK) Coconut Oil (UNII: Q9L0O73W7L) Candelilla Wax (UNII: WL0328HX19) Soybean Oil (UNII: 241ATL177A) Helianthus Annuus Seed Wax (UNII: 42DG15CHXV) Olive Oil (UNII: 6UYK2W1W1E) Castor Oil (UNII: D5340Y2I9G) Rosemary (UNII: IJ67X351P9) Jojoba Oil (UNII: 724GKU717M) Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876) Cocoa Butter (UNII: 512OYT1CRR) .Alpha.-Tocopherol (UNII: H4N855PNZ1) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-100-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/15/2022 VACATION LIP TRIPS DESSERTS BOMBE ALASKA
avobenzone, homosalate, octisalate, and octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.03 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Butyloctyl Salicylate (UNII: 2EH13UN8D3) C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM) Canola Oil (UNII: 331KBJ17RK) Coconut Oil (UNII: Q9L0O73W7L) Candelilla Wax (UNII: WL0328HX19) Soybean Oil (UNII: 241ATL177A) Helianthus Annuus Seed Wax (UNII: 42DG15CHXV) Olive Oil (UNII: 6UYK2W1W1E) Castor Oil (UNII: D5340Y2I9G) Rosemary (UNII: IJ67X351P9) Jojoba Oil (UNII: 724GKU717M) Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876) Cocoa Butter (UNII: 512OYT1CRR) .Alpha.-Tocopherol (UNII: H4N855PNZ1) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-101-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/15/2022 VACATION LIP TRIPS DESSERTS AFTER DINNER MINT
avobenzone, homosalate, octisalate, and octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.03 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Butyloctyl Salicylate (UNII: 2EH13UN8D3) C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM) Canola Oil (UNII: 331KBJ17RK) Coconut Oil (UNII: Q9L0O73W7L) Candelilla Wax (UNII: WL0328HX19) Soybean Oil (UNII: 241ATL177A) Helianthus Annuus Seed Wax (UNII: 42DG15CHXV) Olive Oil (UNII: 6UYK2W1W1E) Castor Oil (UNII: D5340Y2I9G) Rosemary (UNII: IJ67X351P9) Jojoba Oil (UNII: 724GKU717M) Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876) Cocoa Butter (UNII: 512OYT1CRR) .Alpha.-Tocopherol (UNII: H4N855PNZ1) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-102-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/15/2022 VACATION LIP TRIPS DESSERTS STRAWBERRY JELLO
avobenzone, homosalate, octisalate, and octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.03 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Butyloctyl Salicylate (UNII: 2EH13UN8D3) C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM) Canola Oil (UNII: 331KBJ17RK) Coconut Oil (UNII: Q9L0O73W7L) Candelilla Wax (UNII: WL0328HX19) Soybean Oil (UNII: 241ATL177A) Helianthus Annuus Seed Wax (UNII: 42DG15CHXV) Olive Oil (UNII: 6UYK2W1W1E) Castor Oil (UNII: D5340Y2I9G) Rosemary (UNII: IJ67X351P9) Jojoba Oil (UNII: 724GKU717M) Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876) Cocoa Butter (UNII: 512OYT1CRR) .Alpha.-Tocopherol (UNII: H4N855PNZ1) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-103-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/15/2022 VACATION LIP TRIPS DESSERTS BANANAS FOSTER
avobenzone, homosalate, octisalate, and octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.03 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Butyloctyl Salicylate (UNII: 2EH13UN8D3) C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM) Canola Oil (UNII: 331KBJ17RK) Coconut Oil (UNII: Q9L0O73W7L) Candelilla Wax (UNII: WL0328HX19) Soybean Oil (UNII: 241ATL177A) Helianthus Annuus Seed Wax (UNII: 42DG15CHXV) Olive Oil (UNII: 6UYK2W1W1E) Castor Oil (UNII: D5340Y2I9G) Rosemary (UNII: IJ67X351P9) Jojoba Oil (UNII: 724GKU717M) Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876) Cocoa Butter (UNII: 512OYT1CRR) .Alpha.-Tocopherol (UNII: H4N855PNZ1) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-104-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/15/2022 Labeler - Vacation Inc. (117644631) Establishment Name Address ID/FEI Business Operations Raining Rose 083819404 MANUFACTURE(80641-100, 80641-101, 80641-102, 80641-103, 80641-104)