DRUG FACTS

Active Ingredients

Titanium Dioxide (6.0%)

Zinc Oxide (6.0%)

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 or irritation occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Apply liberally 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 of 15 or higher and other sun protection measures including: •Limit time in the sun, especially from 10 am – 2 pm. •Wear long sleeve shirts, pants, hats and sunglasses. •For children under 6 months: consult a physician. Sun Protection Measures:

Inactive Ingredients:

Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Simmondsia Chinensis (Jojoba) Oil, Tocopheryl (VItamin E), Xanthan Gum,

Other Information:

Protect this product from excessive heat and direct sun.

Package Labeling:

Label6

TROPICAL SANDS, SPF-50 BROAD SPECTRUM SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71221-794
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCONUT OIL (UNII: Q9L0O73W7L)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71221-794-54	159 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/22/2017

Labeler - Elements Brands, Inc. (006166707)

Tropical Sands, SPF-50 Broad Spectrum Sunscreen