Vacation By Vacation®

Vacation By Vacation®
SPL v3
SPL
SPL Set ID aef8388f-84bb-4e2b-8ae2-aa64f415a632
Route
TOPICAL
Published
Effective Date 2024-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.9 g) Homosalate (5 g) Octisalate (4.9 g) Octocrylene (8 g)
Inactive Ingredients
Argan Oil Levomenol Butyloctyl Salicylate Sheanut Oil Medium-chain Triglycerides Safflower Oil Coconut Oil Dimethicone Ethyl Ferulate Hyaluronic Acid Ferric Oxide Red Mica Banana Neopentyl Glycol Diethylhexanoate Palmitoyl Tripeptide-1 Sclerocarya Birrea Seed Oil Jojoba Oil Titanium Dioxide .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-15

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs.
Section 50567-7
  • When using this product, keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin.
Warnings
  • For external use only.
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.
Other Information
  • Protect this product from excessive heat and direct sun.
Active Ingredients

Avobenzone (2.9%), Homosalate (5.0%), Octisalate (4.9%), Octocrylene (8.0%)

Inactive Ingredients

Argania Spinosa (Argan) Kernel Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Hyaluronic Acid, Iron Oxides, Mica, Musa Sapientum (Banana) Fruit Extract, Neopentyl Glycol Diethylhexanoate, Palmitoyl Tripeptide-1, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer

Principal Display Panel Kit Carton

"VACATION" by Vacation®

SCENT & SHIMMER DUO

1.7 FL OZ (50 ML) EAU DE TOILETTE + 2.9 FL OZ (86 ML) SHIMMER OIL SPF 30


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs.
Section 50567-7 (50567-7)
  • When using this product, keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Purpose

Sunscreen

Warnings
  • For external use only.
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.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Active Ingredients (Active ingredients)

Avobenzone (2.9%), Homosalate (5.0%), Octisalate (4.9%), Octocrylene (8.0%)

Inactive Ingredients (Inactive ingredients)

Argania Spinosa (Argan) Kernel Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Hyaluronic Acid, Iron Oxides, Mica, Musa Sapientum (Banana) Fruit Extract, Neopentyl Glycol Diethylhexanoate, Palmitoyl Tripeptide-1, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

"VACATION" by Vacation®

SCENT & SHIMMER DUO

1.7 FL OZ (50 ML) EAU DE TOILETTE + 2.9 FL OZ (86 ML) SHIMMER OIL SPF 30


Advanced Ingredient Data


Raw Label Data

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