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NDC 61477-0219-11 ALOE UP SPORT NATURAL BALM 2; 6.5; 5; 1.5 g/100g; g/100g; g/100g; g/100g Details

ALOE UP SPORT NATURAL BALM 2; 6.5; 5; 1.5 g/100g; g/100g; g/100g; g/100g

ALOE UP SPORT NATURAL BALM is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	61477-0219
Product ID	61477-219_dc93fd51-5942-36e3-e053-2995a90ab0c7
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 SPORT NATURAL BALM
Proprietary Name Suffix	SPF-15
Non-Proprietary Name	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	2; 6.5; 5; 1.5
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; OCTINOXATE; 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 61477-0219-11 (61477021911)

Pricing Information	N/A
NDC Package Code	61477-219-11
Billing NDC	61477021911
Package	4.25 g in 1 TUBE (61477-219-11)
Marketing Start Date	2014-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3de029ed-97f7-4cb3-a32e-d412bf3b5874 Details

ACTIVE INGREDIENTS

Avobenzone (2%)

Octinoxate (6.5%)

Octisalate (5%)

Octocrylene (1.5%)

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, Avocado Oil, Beeswax, BHT, Canola Oil, Caprylic/Capric Triglyceride, Castor Seed Oil, Coconut Oil,

Hydrogenated Vegetable Oil, Lanolin Oil, Mango Butter, Sunflower Seed Oil, Tocopherol, Tocopheryl Acetate.

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 SPORT NATURAL BALM SPF-15

avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61477-219
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVOCADO OIL (UNII: 6VNO72PFC1)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANOLA OIL (UNII: 331KBJ17RK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CASTOR OIL (UNII: D5340Y2I9G)
COCONUT OIL (UNII: Q9L0O73W7L)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
LANOLIN (UNII: 7EV65EAW6H)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61477-219-11	4.25 g in 1 TUBE; Type 0: Not a Combination Product	02/24/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/24/2014

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)

Revised: 4/2022

Document Id: dc93fd51-5942-36e3-e053-2995a90ab0c7

Set id: 3de029ed-97f7-4cb3-a32e-d412bf3b5874

Version: 3

Effective Time: 20220413