b.tan beach please spf 7

b.tan beach please spf 7
SPL v5
SPL
SPL Set ID bdc07d83-a34f-5262-e053-2995a90acfc3
Route
topical
Published
Effective Date 2021-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (6 g) octisalate (5 g) octocrylene (8 g)
Inactive Ingredients
phenoxyethanol vinylpyrrolidone/hexadecene copolymer tricaprin grape seed oil panthenol alpha-tocopherol acetate ascorbic acid olive oil argan oil sclerocarya birrea seed oil silicon dioxide c13-15 alkane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-03-17

Description

Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 8%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 8%

Indications and Usage
  • 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.
Dosage and Administration

Directions

  • Apple liberally 15 minutes before sun exposure.
  • Reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months of age: ask a doctor.
  • Sun Protection Measures.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am-2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses.
Description

Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 8%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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. Keep away from face to avoid breathing it.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Silica, C13-14 Alkane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Vitis Vinifera (Grape) Seed Oil, Fragrance (Parfum), Argania Spinosa (Argan) Kernel Oil, Sclerocarya Birrea (Marula) Leaf Extract, Tocopheryl Acetate, Ascorbic Acid, Panthenol

Section 51945-4

Section 53413-1

call 1800-914-3880

Section 55105-1

Sunscreen

Section 60561-8

Protect this product from excessive heat and direct sun.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 8%

Indications and Usage (34067-9)
  • 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.
Dosage and Administration (34068-7)

Directions

  • Apple liberally 15 minutes before sun exposure.
  • Reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months of age: ask a doctor.
  • Sun Protection Measures.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am-2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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. Keep away from face to avoid breathing it.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Silica, C13-14 Alkane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Vitis Vinifera (Grape) Seed Oil, Fragrance (Parfum), Argania Spinosa (Argan) Kernel Oil, Sclerocarya Birrea (Marula) Leaf Extract, Tocopheryl Acetate, Ascorbic Acid, Panthenol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

call 1800-914-3880

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)