Tan De Soleil Orange Tanning Balm Spf-6

Tan De Soleil Orange Tanning Balm Spf-6
SPL v1
SPL
SPL Set ID 5343f359-6074-467c-99bb-f08a7ca2df41
Route
TOPICAL
Published
Effective Date 2024-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (30 mg) Octisalate (40 mg)
Inactive Ingredients
Shea Butter Ferric Oxide Red Isopropyl Myristate Mineral Oil Ceresin Paraffin Petrolatum Cocoa Butter .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Homosalate 3.00% Octisalate 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 3.00% Octisalate 4.0%

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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 liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 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

Homosalate 3.00%

Octisalate 4.0%

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

Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Iron Oxide (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Theobroma Cacao (Cocoa) Butter), I-Tyrosine, Tocopheryl Acetate (Vitamin E), D&C Red#17.

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
  • 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 liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 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)

Homosalate 3.00%

Octisalate 4.0%

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

Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Iron Oxide (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Theobroma Cacao (Cocoa) Butter), I-Tyrosine, Tocopheryl Acetate (Vitamin E), D&C Red#17.

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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