VACATION GRAND CUVEE SHIMMER SPF 30- avobenzone, homosalate, octisalate, and octocrylene oil

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone (3.0%), Homosalate (5.1%), Octisalate (5.0%), Octocrylene (8.5%)

Purpose

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. If swallowed, 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-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.

Inactive Ingredients

Argania Spinosa (Argan) Kernel Oil, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Caesalpinia Sappan Bark Extract, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Iron Oxides, Mica, Musa Paradisiaca (Banana) Fruit Extract, Palmitoyl Tripeptide-1, Prunus Persica (Peach) Kernel Oil, Sclerocarya Birrea (Marula) Kernel Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Tin Oxide, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Grape) Seed Oil

Other Information

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed by Vacation Inc.
936 SW 1st Ave #888, Miami, FL 33130

PRINCIPAL DISPLAY PANEL - 86 ML Bottle Label

"GRAND CUVÉE"
SHIMMER OIL
SPF 30

Vacation®

BROAD SPECTRUM
SPF 30 SUNSCREEN OIL

WATER RESISTANT (80 MINUTES)

2.9 FL OZ / 86 ML

INGREDIENTS AND APPEARANCE

VACATION GRAND CUVEE SHIMMER SPF 30 
avobenzone, homosalate, octisalate, and octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	5.1 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	8.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LEVOMENOL (UNII: 24WE03BX2T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
SHEANUT OIL (UNII: O88E196QRF)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BIANCAEA SAPPAN BARK (UNII: R6995U1QSX)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCONUT OIL (UNII: Q9L0O73W7L)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
Dimethicone (UNII: 92RU3N3Y1O)
Ethyl Ferulate (UNII: 5B8915UELW)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Hyaluronic Acid (UNII: S270N0TRQY)
FERROUS OXIDE (UNII: G7036X8B5H)
Mica (UNII: V8A1AW0880)
BANANA (UNII: 4AJZ4765R9)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)
PERSIC OIL (UNII: 5M26W7T072)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JOJOBA OIL (UNII: 724GKU717M)
Squalene (UNII: 7QWM220FJH)
STANNIC OXIDE (UNII: KM7N50LOS6)
Titanium Dioxide (UNII: 15FIX9V2JP)
Tocopherol (UNII: R0ZB2556P8)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-525-03	147 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	03/15/2026

Labeler - Vacation INC. (117644631)