ALOE UP LIGHT TANNING OIL SPF-6- avobenzone, octyl salicylate, homosalate, octocrylene spray

ALOE UP LIGHT TANNING OIL by

Drug Labeling and Warnings

ALOE UP LIGHT TANNING OIL 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 (1.0%)

Octyl Salicylate (3.0%)

Homosalate (1.0%)

Octocrylene (.85%)

PURPOSE:

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

DIRECTIONS:

Apply liberally. Reapply after swimming or after excessive sweating.

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 prevent sunburn, not skin cancer or early skin aging.
For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.
Stop use and ask a doctor if rash occurs

Flammable: Do not use near heat, flame or while smoking.

INACTIVE INGREDIENTS

Aloe Oil Extract, Coconut Oil, Palm Oil, Banana Oil, Apricot Oil, Almond Oil, Tocopheryl Acetate (Vitamin E).

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 LIGHT TANNING OIL  SPF-6
avobenzone, octyl salicylate, homosalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.85 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
PALM OIL (UNII: 5QUO05548Z)
BANANA (UNII: 4AJZ4765R9)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALMOND OIL (UNII: 66YXD4DKO9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-226-24	120 mL in 1 BOTTLE, SPRAY; 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)