Summer Gelee Spf-30

Summer Gelee Spf-30
SPL v1
SPL
SPL Set ID bc85db65-2acc-4b39-9189-f8916c487b61
Route
TOPICAL
Published
Effective Date 2024-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Chinese Cinnamon Oil Ferric Oxide Red Isopropyl Myristate Mineral Oil Ceresin Paraffin Petrolatum .alpha.-tocopherol Acetate Tridecyl Salicylate D&c Red No. 17

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-06

Description

Homosalate 10.00%, Octisalate 5.00%, Octocrylene 5.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.00%, Octisalate 5.00%, Octocrylene 5.00%

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 aging caused by the sun.
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 a broad spectrum SPF 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, & sunglasses.
Package Labeling:

Active Ingredients

Homosalate 10.00%, Octisalate 5.00%, Octocrylene 5.00%

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Cinnamomum Cassia Oil, Hydrogenated Vegetable Oil, Iron Oxides (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, 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:

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 aging caused by the sun.
Purpose

Sunscreen

Warnings:

For external use only.

Do Not Use (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 a broad spectrum SPF 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, & sunglasses.
Package Labeling:

Active Ingredients

Homosalate 10.00%, Octisalate 5.00%, Octocrylene 5.00%

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Cinnamomum Cassia Oil, Hydrogenated Vegetable Oil, Iron Oxides (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, 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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