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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Available from:
Aloe Care International, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
SUNSCREEN HELPS PREVENT SUNBURN.
Authorization status:
OTC monograph not final
Authorization number:
61477-226-24

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

octocrylene spray

Aloe Care International, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ALOE UP LIGHT TANNING OIL SPF-6

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. 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

ALOE UP LIGHT TANNING OIL SPF-6

avobenzone, octyl salicylate, homosalate, octocrylene spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 1477-226

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

1 g in 10 0 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

3 g in 10 0 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

1 g in 10 0 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

0 .8 5 g in 10 0 mL

Aloe Care International, LLC

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

PALM O IL (UNII: 5QUO0 5548 Z)

BANANA (UNII: 4AJZ476 5R9 )

APRICO T KERNEL O IL (UNII: 54JB35T0 6 A)

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 1477-226 -

120 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/17/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 5/17/20 19

Labeler -

Aloe Care International, LLC (938242187)

Registrant -

Aloe Care International, LLC (938242187)

Revised: 12/2019

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