MINERAL FACE ROSE ESSENCE TINTED MOISTURIZER SPF 20 BROAD SPECTRUM- sunscreen lotion

Mineral Face Rose Essence Tinted Moisturizer by

Drug Labeling and Warnings

Mineral Face Rose Essence Tinted Moisturizer by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 4.2%

Purpose

Sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), dereases 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 doctor if skin rash ocurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

apply liberally 15 minutes before sun exposure

reapply:

• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

Sun Protection Measures. 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 10am-2pm
• wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Inactive ingredients

Aluminum Hydroxide, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (ORGANIC Safllower) Seed Oil, Citrus Aurantium Dulcis (ORGANIC Orange) Fruit Water, Cocoglycerides, Corandrum Sativum (Coriander) Fruit Oil, Cucumis Sativus (ORGANIC Cucumber) Fruit Extract, Euterpe Oleracea (ORGANIC Acai) Fruit Oil, Glycerin (ORGANIC), Helianthus Annuus (ORGANIC Sunflower) Seed Extract, Hydrogen Dimethicone, Hydrogenated Soybean Oil, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Isopropyl Titanium Trisostearate, Linum Usitatissimum (ORGANIC Linseed) Seed Oil, Mica, Plankton Extract, Propanendiol, Rosa Samascena Flower Oil, Salvia Sclarea (Clary) Extract, Synthetic Wax, Tocopherol, Trisodium Ethylenediamine Disuccinate, Water, Xanthan Gum

Other information

protect this product from excessive heat and direct sun

PDP

INGREDIENTS AND APPEARANCE

MINERAL FACE ROSE ESSENCE TINTED MOISTURIZER  SPF 20 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)
MICA (UNII: V8A1AW0880)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
CORIANDER OIL (UNII: 7626GC95E5)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
CUCUMBER (UNII: YY7C30VXJT)
SUNFLOWER SEED (UNII: R9N3379M4Z)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
LINSEED OIL (UNII: 84XB4DV00W)
SAFFLOWER OIL (UNII: 65UEH262IS)
ACAI OIL (UNII: Z0W6766A2W)
TOCOPHEROL (UNII: R0ZB2556P8)
STANNIC OXIDE (UNII: KM7N50LOS6)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
RHODINOL (UNII: 1V437W60X9)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ORANGE (UNII: 5EVU04N5QU)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-123-11	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2015

Labeler - Bell International Laboratories, Inc. (967781555)