Search by Drug Name or NDC

NDC 61477-0226-24 ALOE UP LIGHT TANNING OIL 1; 1; 3; .85 g/100mL; g/100mL; g/100mL; g/100mL Details

ALOE UP LIGHT TANNING OIL 1; 1; 3; .85 g/100mL; g/100mL; g/100mL; g/100mL

ALOE UP LIGHT TANNING OIL is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	61477-0226
Product ID	61477-226_dc94971d-133e-9018-e053-2a95a90ad2b2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ALOE UP LIGHT TANNING OIL
Proprietary Name Suffix	SPF-6
Non-Proprietary Name	AVOBENZONE, OCTYL SALICYLATE, HOMOSALATE, OCTOCRYLENE
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	1; 1; 3; .85
Active Ingredient Units	g/100mL; g/100mL; g/100mL; g/100mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Aloe Care International, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61477-0226-24 (61477022624)

Pricing Information	N/A
NDC Package Code	61477-226-24
Billing NDC	61477022624
Package	120 mL in 1 BOTTLE, SPRAY (61477-226-24)
Marketing Start Date	2019-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c65cb736-a82f-4df5-ae53-1a40092c41f5 Details

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.

SPL UNCLASSIFIED SECTION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61477-226-24	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/17/2019

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

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)

Revised: 4/2022

Document Id: dc94971d-133e-9018-e053-2a95a90ad2b2

Set id: c65cb736-a82f-4df5-ae53-1a40092c41f5

Version: 4

Effective Time: 20220413