BROAD SPECTRUM SPF 50 FACES MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

Broad Spectrum SPF 50 Faces Mineral Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF 50 Faces Mineral Sunscreen 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 8%

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 Salicilate, 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, Fragrance (Parfum), Cocos Nucifera 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

BROAD SPECTRUM SPF 50 FACES MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-190
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	80 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-190-02	59 mL in 1 TUBE; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/15/2020

Labeler - Aruba Aloe Balm NV (855442273)