FDA.reportPublic FDA data

Aloe Up Coco-Mango SPF 30 Sunscreen Lotion

Manufacturer
Prime Enterprises Inc.
Effective date
2023-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:37

Label at a glance#

ProductAloe Up Broad Spectrum SPF 30 Sunscreen
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, es...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 3.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctorif rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

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

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excesive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-950-2563 •www.aloeup.com

Aloe Up Coco-Mango SPF 30 Sunscreen Lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-063158443-0631-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
COCOA BUTTER512OYT1CRRIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALLANTOIN344S277G0ZIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
POLYSORBATE 207T1F30V5YHIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
SORBITOL506T60A25RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0219f330-81bd-c67f-e063-6394a90a4da90219ca96-e695-55a4-e063-6294a90a7dd72023-08-04WarningsExact identifier
spl id: 0219f330-81bd-c67f-e063-6394a90a4da9
spl set id: 0219ca96-e695-55a4-e063-6294a90a7dd7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.