aloe up sport - medicated lip balm spf-30 (61477-224)

aloe up sport - medicated lip balm spf-30 (61477-224)
SPL v8
SPL
SPL Set ID 859b6d3f-b1ca-4966-8f0c-f9afa0d5864c
Route
topical
Published
Effective Date 2019-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2 g) homosalate (7.5 g) octisalate (5 g) octocrylene (2.5 g) oxybenzone (6 g)
Inactive Ingredients
aloe vera leaf camphor (synthetic) canola oil cetyl alcohol menthol ceresin petrolatum titanium dioxide tocopherol triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-05-17

Purpose

SUNSCREEN

Description

AVOBENZONE (2%) HOMOSALATE (7.5%) OCTISALATE (5%) OCTOCRYLENE (2.5%) OXYBENZONE (6%)


Medication Information

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases 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.

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Uses

HELPS PREVENT SUNBURN.

Purpose

SUNSCREEN

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

Other Information

• Protect this product from excessive heat and direct sun

Inactive Ingredients

Aloe Vera Leaf Extract, Camphor Powder, Canola Oil, Castor Oil, Cetyl Alcohol, Menthol, Ozokerite Wax, Petrolatum, Titanium

Dioxide, Tocopherol, Triethoxycaprylylsilane.

Description

AVOBENZONE (2%) HOMOSALATE (7.5%) OCTISALATE (5%) OCTOCRYLENE (2.5%) OXYBENZONE (6%)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Active Ingredients

AVOBENZONE (2%)

HOMOSALATE (7.5%)

OCTISALATE (5%)

OCTOCRYLENE (2.5%)

OXYBENZONE (6%)

Questions Or Comments?

Toll Free 800-950-2563 www.aloeup.com


Structured Label Content

Warnings (WARNINGS)

Skin Cancer/Skin Aging Alert: Spending time in the sun increases 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.

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Uses (USES)

HELPS PREVENT SUNBURN.

Purpose (PURPOSE)

SUNSCREEN

Directions (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

Other Information (OTHER INFORMATION)

• Protect this product from excessive heat and direct sun

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Vera Leaf Extract, Camphor Powder, Canola Oil, Castor Oil, Cetyl Alcohol, Menthol, Ozokerite Wax, Petrolatum, Titanium

Dioxide, Tocopherol, Triethoxycaprylylsilane.

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 51945-4 (51945-4)

Active Ingredients (ACTIVE INGREDIENTS)

AVOBENZONE (2%)

HOMOSALATE (7.5%)

OCTISALATE (5%)

OCTOCRYLENE (2.5%)

OXYBENZONE (6%)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Toll Free 800-950-2563 www.aloeup.com


Advanced Ingredient Data


Raw Label Data

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