Label: ARUBA ALOE SPORT LINE BROAD SPECTRUM SPF 50 ANTI CHAFING- titanium dioxide, zinc oxide cream
- NDC Code(s): 53675-186-00
- Packager: Aruba Aloe Balm NV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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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
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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:
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INGREDIENTS AND APPEARANCE
ARUBA ALOE SPORT LINE BROAD SPECTRUM SPF 50 ANTI CHAFING
titanium dioxide, zinc oxide creamProduct 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)
