ALOE UP COCO-MANGO SPF-10- avobenzone, octisalate, octocrylene lotion

ALOE UP COCO-MANGO by

Drug Labeling and Warnings

ALOE UP COCO-MANGO 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%)

OCTISALATE (3.75%)

OCTOCRYLENE (3.0%)

PURPOSE

SUNSCREEN

USES

• helps prevent sunburn

DIRECTIONS

• apply liberally 15 minutes before sun exposure

reapply:
after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months: Ask a doctor

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. If product is 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.

Stop use and ask a doctor if rash occurs

INACTIVE INGREDIENTS

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, C12-15 Alkyl Benzoate,Camellia Sinensis Leaf Extract, Carbomer, Fragrance, Iodopropynyl Butylcarbamate, Isodecyl Neopentanoate, Isopropylphthalimide, PEG-8, Phenoxyethanol, Polysorbate 20, Polyethylene, Propanediol, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine,Trisodium Ethylenediamine Disuccinate, Water

OTHER INFORMATION

• protect this container from excessive heat and direct sun.

QUESTIONS AND COMMENTS?

Call toll free 1-800-950-2563

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP COCO-MANGO  SPF-10
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-222
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	3.75 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BUTYLPHTHALIDE (UNII: 822Q956KGM)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
SORBITOL (UNII: 506T60A25R)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-222-14	118 mL in 1 TUBE; Type 0: Not a Combination Product	02/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/18/2019

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)