Label: VACATION SPF 30 MINERAL- zinc oxide lotion
- NDC Code(s): 80641-009-01
- Packager: Vacation Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 March 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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 -
INACTIVE INGREDIENT
Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol , Cucumis Sativus (Cucumber) Fruit Extract, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Glycerin, Glyceryl Behenate/Eicosadioate, Isododecane, Isopropyl Myristate, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Polyglyceryl-3 Oleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Tocopherol (Vitamin E), Water, Xanthan Gum
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VACATION SPF 30 MINERAL
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PROPANEDIOL (UNII: 5965N8W85T) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CUCUMBER (UNII: YY7C30VXJT) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) NIACINAMIDE (UNII: 25X51I8RD4) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SODIUM GLUCONATE (UNII: R6Q3791S76) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-009-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/01/2023 Labeler - Vacation Inc. (117644631)
