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NDC 61477-0222-14 ALOE UP COCO-MANGO 1; 3.75; 3 g/100mL; g/100mL; g/100mL Details

ALOE UP COCO-MANGO 1; 3.75; 3 g/100mL; g/100mL; g/100mL

ALOE UP COCO-MANGO is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is AVOBENZONE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	61477-0222
Product ID	61477-222_dc93c942-cb89-763e-e053-2995a90a9538
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 COCO-MANGO
Proprietary Name Suffix	SPF-10
Non-Proprietary Name	AVOBENZONE, OCTISALATE, OCTOCRYLENE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	1; 3.75; 3
Active Ingredient Units	g/100mL; g/100mL; g/100mL
Substance Name	AVOBENZONE; 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 61477-0222-14 (61477022214)

Pricing Information	N/A
NDC Package Code	61477-222-14
Billing NDC	61477022214
Package	118 mL in 1 TUBE (61477-222-14)
Marketing Start Date	2019-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3a0cbc85-13f1-48ad-94b4-08958fe315a4 Details

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

SPL UNCLASSIFIED SECTION

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

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	3.75 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)

Revised: 4/2022

Document Id: dc93c942-cb89-763e-e053-2995a90a9538

Set id: 3a0cbc85-13f1-48ad-94b4-08958fe315a4

Version: 3

Effective Time: 20220413