Spf 15 Lip Balm And Spf 30sunscreen Stick

Spf 15 Lip Balm And Spf 30sunscreen Stick
SPL v1
SPL
SPL Set ID 0b385246-dc77-6874-e063-6394a90a5959
Route
TOPICAL
Published
Effective Date 2018-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Homosalate (80 mg) Octocrylene (55 mg) Octisalate (30 mg)
Inactive Ingredients
Mineral Oil Yellow Wax Ceresin Coconut Oil Ethylhexyl Palmitate High Density Polyethylene Tridecyl Trimellitate Shea Butter Butylated Hydroxytoluene .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-01

Description

Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2%

Uses

• Helps prevent sunburn.

Warnings

For external use only.

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: Ask a doctor.

Do Not Use

on damaged or broken skin.

Questions?

Call AP Specialties

Other Information

• Protect from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Homosalate 2%

Avobenzone 8%

Octocrylene 5.5%

Octisalate 2%

Inactive Ingredients

Mineral Oil, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

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 Reach of Children.

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


Structured Label Content

Uses

• Helps prevent sunburn.

Purpose

Sunscreen

Warnings

For external use only.

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: Ask a doctor.

Do Not Use (Do not use)

on damaged or broken skin.

Questions?

Call AP Specialties

Other Information

• Protect from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Homosalate 2%

Avobenzone 8%

Octocrylene 5.5%

Octisalate 2%

Inactive Ingredients

Mineral Oil, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

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

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


Advanced Ingredient Data


Raw Label Data

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