VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene oil

VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN by

Drug Labeling and Warnings

VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Vacation Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%)

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. In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating.
• 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.

Inactive ingredients

Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Caprylic/ Capric Triglyceride, Fragrance, Methyl Dihydroabietate, Octyldodecanol, Passiflora Edulis (Passionfruit) Seed Oil, Phenoxyethanol, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Vitis Vinifera (Chardonnay Grape) Seed Oil, VP/Hexadecene Copolymer

Other information

• Protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label

Vacation®

Chardonnay Oil
BROAD SPECTRUM SPF 30 SUNSCREEN OIL

Chardonnay Seed Sunscreen Oil
by The Eternal Vacation® of Miami
"Clean, Lightweight & Refreshing"
"For an Enviable Shine"

SPF 30

3.4 FL OZ / 100 ML

INGREDIENTS AND APPEARANCE

VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-003
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	10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Levomenol (UNII: 24WE03BX2T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Sheanut Oil (UNII: O88E196QRF)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Methyl Dihydroabietate (UNII: 7666FJ0J9F)
Octyldodecanol (UNII: 461N1O614Y)
Passiflora Edulis Seed Oil (UNII: F3VOA31UHQ)
Phenoxyethanol (UNII: HIE492ZZ3T)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
Jojoba Oil (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-003-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2021
2	NDC: 80641-003-02	7 mL in 1 PACKET; Type 0: Not a Combination Product	04/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/19/2021

Labeler - Vacation Inc. (117644631)