ALOE UP MEDICATED LIP BALM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick

ALOE UP MEDICATED LIP BALM by

Drug Labeling and Warnings

ALOE UP MEDICATED LIP BALM by is a Otc medication manufactured, distributed, or labeled by Aloe Care International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE (2%)

HOMOSALATE (7.5%)

OCTISALATE (5%)

OCTOCRYLENE (2.5%)

OXYBENZONE (6%)

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

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

KEEP OUT OF REACH OF CHILDREN

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

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.

INACTIVE INGREDIENTS

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

OTHER INFORMATION

Protect this product from excessive heat and direct sun

QUESTIONS OR COMMENTS?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP MEDICATED LIP BALM  SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CANOLA OIL (UNII: 331KBJ17RK)
CETYL ALCOHOL (UNII: 936JST6JCN)
MENTHOL (UNII: L7T10EIP3A)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-224-11	4.25 g in 1 TUBE; Type 0: Not a Combination Product	05/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/17/2019

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)