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), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acetylated Hydrogenated Vegetable Glyceride, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Butyloctyl Salicylate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Polyhydroxystearic Acid, Stearic Acid, Alumina, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Beheneth-25 Methacrylate Copolymer, Tocopheryl (Vitamin E) Acetate, Sodium Hydroxide.

Package Labeling:

Tube

BROAD SPECTRUM SPF 30 WATER RESISTANT MINERAL SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53675-183
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53675-183-30	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/01/2019

Labeler - Aruba Aloe Balm NV (855442273)

Broad Spectrum SPF 30 Water Resistant Mineral Sunscreen