VACATION SPF 30 MINERAL- zinc oxide lotion 
Vacation Inc.

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.

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Vacation - SPF 30 Mineral Lotion

Zinc Oxide 15.5%

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

For external use only
Do not use on damaged or broken skin
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. In case of ingestion, get medical help or contact a Poison Control Center right away.

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

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

• Protect this product from excessive heat and direct sun

1

VACATION SPF 30 MINERAL 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80641-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80641-009-01100 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/2023
Labeler - Vacation Inc. (117644631)

Revised: 3/2023
Document Id: f69513ae-f211-075f-e053-2a95a90a9b2e
Set id: f69513ae-f210-075f-e053-2a95a90a9b2e
Version: 1
Effective Time: 20230310
 
Vacation Inc.