Aloe Up - Aloe Kote Spf-25 (61477-225)

Aloe Up - Aloe Kote Spf-25 (61477-225)
SPL v7
SPL
SPL Set ID 12e78c53-ba19-4c8e-bd2f-8c85fccbc179
Route
TOPICAL
Published
Effective Date 2019-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.4 g) Homosalate (14.5 g) Oxybenzone (5.9 g)
Inactive Ingredients
Aloe Vera Leaf Eicosyl Povidone Ceresin Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-17

Description

OCTINOXATE (7.4%) OXYBENZONE (5.9%) HOMOSALATE (14.5%)

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

OCTINOXATE (7.4%) OXYBENZONE (5.9%) HOMOSALATE (14.5%)

Uses

HELPS PREVENT SUNBURN.

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

Purpose:

SUNSCREEN

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.

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

Active Ingredients:

OCTINOXATE (7.4%)

OXYBENZONE (5.9%)

HOMOSALATE (14.5%)

Inactive Ingredients

Aloe Oil Extract, Ganex V-220, Ozokerite Wax #871, Protopet Alba USP

Questions Or Comments?

Toll Free 800-950-2563

www.aloeup.com


Structured Label Content

Uses (USES)

HELPS PREVENT SUNBURN.

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)

Purpose: (PURPOSE:)

SUNSCREEN

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.

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

Active Ingredients: (ACTIVE INGREDIENTS:)

OCTINOXATE (7.4%)

OXYBENZONE (5.9%)

HOMOSALATE (14.5%)

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Oil Extract, Ganex V-220, Ozokerite Wax #871, Protopet Alba USP

Questions Or Comments? (Questions or comments?)

Toll Free 800-950-2563

www.aloeup.com


Advanced Ingredient Data


Raw Label Data

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