VACATION SPF 30 CHARDONNAY OIL- avobenzone, homosalate, octisalate, octocrylene oil 
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 Chardonnay Oil

Avobenzone (2.9%)

Homosalate (9.8%)

Octisalate (4.9%)

Octocrylene (9.5%)

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.

Warnings

• 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 sunglasses • Children under 6 months of age: ask a physician.

Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Fragrance, Isopropyl Myristrate, Methyl Dihydroabietate, Passiflora Edulis (Passionfruit) Seed Oil, Polyester-8, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E),Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Chardonnay Grape) Seed Oil

Other Information

• Protect this product from excessive heat and direct sun.

1

VACATION SPF 30 CHARDONNAY OIL 
avobenzone, homosalate, octisalate, octocrylene oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80641-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SHEANUT OIL (UNII: O88E196QRF)  
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80641-008-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
2NDC:80641-008-0230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2023
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: f6947fb0-21c8-71f0-e053-2995a90aadbf
Set id: f694752d-4839-3768-e053-2995a90a5d3e
Version: 1
Effective Time: 20230310
 
Vacation Inc.