FDA.reportPublic FDA data

Aloe Up

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:03:52

Label at a glance#

ProductAloe Up Dark Tanning Oil SPF 4
Active ingredientAVOBENZONE, OCTOCRYLENE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

spray liberally and spread by hand 15 minutes before sun exposure hold container 4 to 6 inches from the skin to apply do not spray directly into face. Spray on hands then apply to face. do not apply in windy condiions use in well-ventillated area reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1%

Octocrylene 0.85%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

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.

OTHER SAFETY INFORMATION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120 oF

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

OTHER SAFETY INFORMATION

Flammable: Do not use near heat, flame or while smoking.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray liberally and spread by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy condiions
  • use in well-ventillated area
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Ascorbic Acid, C12-15 Alkyl Benzoate, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Retinyl Palmitate, Ricinus Communis (Castor) Seed Oil, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-950-2563

Aloe Up Dark Tanning Oil SPF 4 Sunscreen Mist

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0152-42024-05-02C16284748780-1f386c649-d147-0266-e053-dadaa90a7c1a9d388469-53c5-9246-e053-2995a90a6c7f
13630-0152-42023-01-30C16284748780-1f386c649-d147-0266-e053-dadaa90a7c1a9d388469-53c5-9246-e053-2995a90a6c7f

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-015213630-0152-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RIACT
CASTOR OILD5340Y2I9GIACT
MINERAL OILT5L8T28FGPIACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALCOHOL3K9958V90MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
DIBUTYL MALEATE4X371TMK9KIACT
VINYL ACETATEL9MK238N77IACT
ISOBORNYL ACRYLATEIX0PRH184PIACT

Source Document#

Source XML · Source PDF

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
177d5f35-868e-c79f-e063-6394a90a0be29d388469-53c5-9246-e053-2995a90a6c7f2024-05-02WarningsExact identifier
spl id: 177d5f35-868e-c79f-e063-6394a90a0be2
spl set id: 9d388469-53c5-9246-e053-2995a90a6c7f

Reported adverse events (FAERS/openFDA)#

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