tanning club golden glow tanning oil spf-15

tanning club golden glow tanning oil spf-15
SPL v1
SPL
SPL Set ID 748a9933-02a3-48c1-8636-8f0468f66a13
Route
topical
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) octisalate (40 mg) octocrylene (50 mg)
Inactive Ingredients
shea butter medium-chain triglycerides safflower coconut oil carrot seed oil olive oil cocoa .alpha.-tocopherol acetate grape seed oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-27

Purpose

Sunscreen

Description

Avobenzone 3.00% Octisalate 4.00% Octocrylene 5.00%


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Octisalate 4.00% Octocrylene 5.00%

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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.
Questions

-(877) TAN-0052 -(877) 826-0052

Warnings:

For external use only

Do Not Use
  • on damaged or broken skin.
Drug Facts

Directions:
  • Apply liberally15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 this risk, regularly use a sunscreen with 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.
Package Labeling:

Active Ingredients

Avobenzone 3.00%

Octisalate 4.00%

Octocrylene 5.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Oil, Olea Europaea (Olive) Oil, Parfum (Fragrance), Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate ( Vitamin E), Vitis Vinifera (Grape) Seed Oil.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose (PURPOSE)

Sunscreen

Uses: (USES:)
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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.
Questions (QUESTIONS)

-(877) TAN-0052 -(877) 826-0052

Warnings: (WARNINGS:)

For external use only

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Directions: (DIRECTIONS:)
  • Apply liberally15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 this risk, regularly use a sunscreen with 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.
Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Avobenzone 3.00%

Octisalate 4.00%

Octocrylene 5.00%

Other Information: (OTHER INFORMATION:)
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Oil, Olea Europaea (Olive) Oil, Parfum (Fragrance), Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate ( Vitamin E), Vitis Vinifera (Grape) Seed Oil.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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