360 By Qur Lemon Verbena Lip Balm

360 By Qur Lemon Verbena Lip Balm
SPL v3
SPL
SPL Set ID bedb14c2-9181-5970-e053-2a95a90a4161
Route
TOPICAL
Published
Effective Date 2021-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (50 mg) Octocrylene (30 mg) Octisalate (22 mg) Avobenzone (5 mg)
Inactive Ingredients
Coconut Oil Polybutene (1400 Mw) Ethylhexyl Palmitate Candelilla Wax Bis-diglyceryl Polyacyladipate-1 Shea Butter Stevioside Olive Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-24

Description

Octyl methoxycinnamate 5%, Octocrylene 3%, Octisalate 2.2%, Avobenzone 0.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octyl methoxycinnamate 5%, Octocrylene 3%, Octisalate 2.2%, Avobenzone 0.5%

Use

Helps prevent sunburn.

Warnings

For external use only.

Directions
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every two hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • For children under 6 months, consult a physician.
Do Not Use

on damaged or broken skin.

Drug Facts

Other Information

Protect this product from excessive heat and direct sunlight.

Package Labeling:

Active Ingredients

Octyl methoxycinnamate 5%, Octocrylene 3%, Octisalate 2.2%, Avobenzone 0.5%

Inactive Ingredients

Olea Europaea (Olive) Fruit Oil, Synthetic Wax, Hydrogenated Vegetable Oil, Cocos Nucifera (Coconut) Oil, Polybutene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) wax, Bis-Diglyceryl Polyacyladipate-1, Butyrospermum Parkii (Shea Butter), Fragrance, Stevioside.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs.

Keep Out of the Reach of Children

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

Spending time in the sun increase your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:


Structured Label Content

Use

Helps prevent sunburn.

Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every two hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • For children under 6 months, consult a physician.
Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Other Information (Other information)

Protect this product from excessive heat and direct sunlight.

Package Labeling:

Active Ingredients (Active ingredients)

Octyl methoxycinnamate 5%, Octocrylene 3%, Octisalate 2.2%, Avobenzone 0.5%

Inactive Ingredients (Inactive ingredients)

Olea Europaea (Olive) Fruit Oil, Synthetic Wax, Hydrogenated Vegetable Oil, Cocos Nucifera (Coconut) Oil, Polybutene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) wax, Bis-Diglyceryl Polyacyladipate-1, Butyrospermum Parkii (Shea Butter), Fragrance, Stevioside.

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 occurs.

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Spending time in the sun increase your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:


Advanced Ingredient Data


Raw Label Data

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