ARUBA ALOE SPORT LINE BROAD SPECTRUM SPF 50 ANTI CHAFING- titanium dioxide, zinc oxide cream

Aruba Aloe Sport Line Broad Spectrum SPF 50 Anti Chafing by

Drug Labeling and Warnings

Aruba Aloe Sport Line Broad Spectrum SPF 50 Anti Chafing by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 10% Zinc Oxide 10%

Purpose

Sunscreen

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.

Warnings

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.

Keep out of reach of children.

f swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other Information

• protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water (Aqua/Eau), Decyl Oleate, Petrolatum, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Dicocoyl Pentaerythrityl Distearyl Citrate, Sorbitane Sesquioleate, Dimethicone, Butyloctyl Salicylate, Dimethicone Crosspolymer,  Cetearyl Alcohol, Cera Microcristallina (Microcristalline Wax), Aluminum Stearates, Glycerin, Tocopheryl Acetate (Vitamin E Acetate), Sodium Polyacrylate, Phenoxyethanol, Fragrance (Parfum), Ascorbic Acid (Vitamin C), Simmondsia Chinensis Seed (Jojoba) Oil, Stearic Acid,  Chlorphenesin, Caprylyl Glycol, Citric Acid, Alumina, Polyhydroxystearic Acid.

Package Labeling:

INGREDIENTS AND APPEARANCE

ARUBA ALOE SPORT LINE BROAD SPECTRUM SPF 50 ANTI CHAFING 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DECYL OLEATE (UNII: ZGR06DO97T)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WHITE WAX (UNII: 7G1J5DA97F)
DICOCOYL PENTAERYTHRITYL DISTEARYL CITRATE (UNII: E5UWK4US3M)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
ALUMINUM STEARATES (UNII: O4D7U3B46U)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-186-00	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/15/2020

Labeler - Aruba Aloe Balm NV (855442273)

Establishment
Name	Address	ID/FEI	Business Operations
Aruba Aloe Balm NV		855442273	manufacture(53675-186)