ALOE UP SPF 33 MINERAL- zinc oxide lotion

Aloe UP SPF 33 Mineral by

Drug Labeling and Warnings

Aloe UP SPF 33 Mineral by is a Otc medication manufactured, distributed, or labeled by Aloe Care International, LLC, Inspec Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 20%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

WARNINGS

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs.

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.

DOSAGE & 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 the risk, reguarly use a susncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10am - 2pm.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

OTHER SAFETY INFORMATION

Protect this product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice

Benzyl alcohol

Butyloctyl Salicylate

Caprylic/Capric Triglyceride

Citric Acid

Coco-Caprylate

Coconut Mango Fragrance

Dehydroacetic acid

Glycerin

Glyceryl Stearate

Niacinamide

Panthenol

Polyhydroxystearic Acid

Saccharide Isomerate

Sodium Phytate

Sodium Stearoyl Glutamate

Sucrose Tristearate

Sucrose Palmitate

Tocopheryl acetate

Water

Xanthan gum

QUESTIONS

Questions or Comments?

Call toll free 1-800-950-2563

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP SPF 33 MINERAL 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE (UNII: 4828G836N6)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
FRAGRANCE 13576 (UNII: 5EM498GW35)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CITRIC ACID (UNII: 2968PHW8QP)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM PHYTATE (UNII: 88496G1ERL)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-231-01	30 g in 1 TUBE; Type 0: Not a Combination Product	05/21/2025
2	NDC: 61477-231-03	89 g in 1 TUBE; Type 0: Not a Combination Product	05/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/21/2025

Labeler - Aloe Care International, LLC (938242187)

Registrant - Inspec Solutions, LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions, LLC		081030372	manufacture(61477-231)