SPL v1
SPL
SPL Set ID 20c5fde7-ee8f-4b74-e063-6394a90a93ec
Route
TOPICAL
Published
Effective Date 2024-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.0065 g) Octisalate (0.005 g) Octocrylene (0.0015 g) Avobenzone (0.002 g)
Inactive Ingredients
Sunflower Oil Cannabis Sativa Seed Oil Rosemary Oil Soybean Oil Sunflower Oil Mono/diglycerides Canola Oil Tocopherol Aloe Olive Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-03

Description

Active Ingredients: Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%


Medication Information

Warnings and Precautions

Warnings

  • For External Use Only
  • Do not use on damaged or broken skin
  • Stop and ask a doctor if
    • rash occurs
  • When using this product
  • keep out of eyes. Rinse with water to remove.

Indications and Usage

Uses

  • Helps prevent sunburn
Dosage and Administration

Directions

  • apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor

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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10a.m. - 2p.m.
  • wear long sleeved shirts, pants, hats, and sunglasses.
Description

Active Ingredients: Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Section 43683-2

Corrected Indications and usage section

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

Inactive Ingredients:

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Tocopherol, Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides, Canola Oil. *Organic

Section 51945-4

Section 53413-1

Dist. by: Skin ScriptTM Chandler, AZ 85226

Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active Ingredients:

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60561-8

Other Information

Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps prevent sunburn
Dosage and Administration (34068-7)

Directions

  • apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor

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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10a.m. - 2p.m.
  • wear long sleeved shirts, pants, hats, and sunglasses.
Warnings and Precautions (34071-1)

Warnings

  • For External Use Only
  • Do not use on damaged or broken skin
  • Stop and ask a doctor if
    • rash occurs
  • When using this product
  • keep out of eyes. Rinse with water to remove.

Section 43683-2 (43683-2)

Corrected Indications and usage section

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

Inactive Ingredients:

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Tocopherol, Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides, Canola Oil. *Organic

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Dist. by: Skin ScriptTM Chandler, AZ 85226

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60561-8 (60561-8)

Other Information

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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