ARUBA ALOE SPF 50 MINERAL SUNSCREEN BABIES- titanium dioxide, zinc oxide cream

Aruba Aloe SPF 50 Mineral Sunscreen BABIES by

Drug Labeling and Warnings

Aruba Aloe SPF 50 Mineral Sunscreen BABIES 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.

If 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), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Glyceryl Stearate, Cetearyl Isononanoate, Polysorbate 60, VP/Eicosene Copolymer, Cetearyl Alcohol, Dimethicone Crosspolymer, Dimethicone, Stearic Acid, Ceteareth-20, Propylene Glycol, Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Tocopheryl (Vitamin E) Acetate , Cetyl Palmitate, Ceteareth-12, Caprylyl Glycol, Chlorphenesin, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C), Citric Acid, Disodium EDTA Powder, Triethoxycaprylylsilane, Alumina, Polyhydroxystearic Acid.

Package Labeling:

INGREDIENTS AND APPEARANCE

ARUBA ALOE SPF 50 MINERAL SUNSCREEN BABIES 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-197
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)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCONUT OIL (UNII: Q9L0O73W7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETEARETH-12 (UNII: 7V4MR24V5P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
JOJOBA OIL (UNII: 724GKU717M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-197-01	59 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/20/2022

Labeler - Aruba Aloe Balm NV (855442273)