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NDC 61477-0224-11 ALOE UP MEDICATED LIP BALM 2; 7.5; 5; 2.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g Details

ALOE UP MEDICATED LIP BALM 2; 7.5; 5; 2.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g

ALOE UP MEDICATED LIP BALM is a TOPICAL LIPSTICK in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	61477-0224
Product ID	61477-224_dc93e91c-21e2-d909-e053-2995a90adc96
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 MEDICATED LIP BALM
Proprietary Name Suffix	SPF 30
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	LIPSTICK
Route	TOPICAL
Active Ingredient Strength	2; 7.5; 5; 2.5; 6
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
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 61477-0224-11 (61477022411)

Pricing Information	N/A
NDC Package Code	61477-224-11
Billing NDC	61477022411
Package	4.25 g in 1 TUBE (61477-224-11)
Marketing Start Date	2019-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 859b6d3f-b1ca-4966-8f0c-f9afa0d5864c Details

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

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 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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61477-224-11	4.25 g in 1 TUBE; 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: dc93e91c-21e2-d909-e053-2995a90adc96

Set id: 859b6d3f-b1ca-4966-8f0c-f9afa0d5864c

Version: 5

Effective Time: 20220413