Vacation Spf 50 Classic Lotion

Vacation Spf 50 Classic Lotion
SPL v4
SPL
SPL Set ID f268fb1c-d7c2-f2f9-e053-2995a90a9e22
Route
TOPICAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9.5 g) Avobenzone (2.8 g) Homosalate (9.8 g) Octisalate (4.9 g)
Inactive Ingredients
Banana Phenoxyethanol Sodium Stearoyl Glutamate Butyloctyl Salicylate Dimethicone Hyaluronate Sodium Silicon Dioxide Water Aloe Vera Leaf Shea Butter Ethylhexyl Palmitate Phytate Sodium Glycerin Coconut Oil Tocopherol Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Ethylhexylglycerin Sodium Polyacrylate (2500000 Mw) Niacinamide Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-01

Description

Avobenzone (2.%), Homosalate (9.8%), Octisalate (4.9%), Octocrylene (9.5%)


Medication Information

Warnings and Precautions
  • 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

Description

Avobenzone (2.%), Homosalate (9.8%), Octisalate (4.9%), Octocrylene (9.5%)

Tube

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 50565-1

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

Section 51727-6

Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Musa Paradisiaca (Banana) Fruit Extract, Niacinamide, Phenoxyethanol, Silica, Sodium Hyaluronate, Sodium Phytate, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Water

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone (2.%), Homosalate (9.8%), Octisalate (4.9%), Octocrylene (9.5%)

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.
Back of Jug

Sunjug Front

Other Information

Protect this product from excessive heat and direct sun


Structured Label Content

Tube

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 and Precautions (34071-1)
  • 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

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 51727-6 (51727-6)

Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Musa Paradisiaca (Banana) Fruit Extract, Niacinamide, Phenoxyethanol, Silica, Sodium Hyaluronate, Sodium Phytate, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Water

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone (2.%), Homosalate (9.8%), Octisalate (4.9%), Octocrylene (9.5%)

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.
Back of Jug (back of jug)

Sunjug Front (Sunjug front)

Other Information

Protect this product from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)