Tanning Club Tanning Lotion Spf-8

Tanning Club Tanning Lotion Spf-8
SPL v1
SPL
SPL Set ID bbf9d61e-f2e6-4fde-baad-c412091c60b6
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) Octocrylene (60 mg)
Inactive Ingredients
Aloe Vera Leaf Water Ascorbyl Palmitate Beta Carotene Butyloctyl Salicylate Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Cetyl Alcohol Cetearyl Glucoside Citric Acid Monohydrate Watermelon Carrot Dimethicone Dodecane Glycerin Glyceryl Laurate Glyceryl Monostearate Helianthus Annuus Flowering Top Isododecane C13-14 Isoparaffin Laureth-7 Magnesium Aluminum Silicate Polysorbate 20 Rosemary Saccharide Isomerate Sodium Stearoyl Glutamate Stearyl Alcohol Edetate Sodium .alpha.-tocopherol Acetate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-27

Description

Avobenzone 3.00% Octocrylene 6.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Octocrylene 6.00%

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%

Octocrylene 6.00%

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

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamine C), Beta-Carotene, Butyloctyl Salicylate, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullusn Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Parfum (Fragrance), Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Sodium Stearoyl Glutamate, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum.

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

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.
Purpose (PURPOSE)

Sunscreen

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%

Octocrylene 6.00%

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamine C), Beta-Carotene, Butyloctyl Salicylate, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullusn Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Parfum (Fragrance), Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Sodium Stearoyl Glutamate, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum.

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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