DRUG FACTS

Active Ingredients

Titanium Dioxide, 6.0%

Zinc Oxide, 22.5%

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. Keep product out of eyes. Rinse with water to remove.

Stop use and consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

Apply liberally 15 minutes before sun exposure. at least every two hours, and immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad-spectrum protection and an SPF rating of 15 or higher. Limit time in sleeve shirts, pants, hats and sunglasses. For children under 6 months, consult a physician. ReapplySun protection measures:Other recommendations:

Other 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, tocopherol (vitamin e), xanthan gum

For maximum effectiveness:

Protect this product from excessive heat and direct sunlight.

Package Labeling:

Label3

PHARMACA NATURAL MINERAL SUNSCREEN SPF-50
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62082-057
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	225 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)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62082-057-03	100 mL in 1 TUBE; Type 0: Not a Combination Product	05/20/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/20/2019

Labeler - Pharmaca Integrative Pharmacy, Inc. (031903446)

PHARMACA Natural Mineral Sunscreen SPF-50