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

Purpose

Sunscreen

Description

Homosalate 3.00% Octisalate 4.0%


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

Purpose (PURPOSE)

Sunscreen

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
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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