UV PROTECT FACE SPF 50- zinc oxide, titanium dioxide cream

UV PROTECT FACE SPF 50 by

Drug Labeling and Warnings

UV PROTECT FACE SPF 50 by is a Otc medication manufactured, distributed, or labeled by Naos USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 20%

Titanium Dioxide 8.82%

Purpose

Sunscreen

Uses

Help prevent sunburn.

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 reach of children.

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

Directions

• Apply liberally, and spread evenly by hand 15 min before sun exposure. 
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating
• 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 value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months of age: Ask a doctor.

Other information

• Keep the product between 15-30ºC.
• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Coco-caprylate/caprate, Caprylic/Capric Triglyceride, Methyl Methacrylate Crosspolymer, Dicaprylyl Ether, Dicaprylyl Carbonate, Silica Dimethyl Silylate, Oryza Sativa (Rice) Bran Oil, Polyhydroxystearic Acid, Tocopheryl Acetate, Stearic Acid, Alumina, Fragrance (Parfum), Stearyl Glycyrrhetinate, Tocopherol, Farnesol.

Questions?

Call to 1 877 443 3762

Package Labeling:

INGREDIENTS AND APPEARANCE

UV PROTECT FACE SPF 50 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	882 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
WHITE RICE (UNII: A195V20H7A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
TOCOPHEROL (UNII: R0ZB2556P8)
FARNESOL (UNII: EB41QIU6JL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14324-011-00	1 in 1 BOX	01/31/2018
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/31/2018

Labeler - NAOS (263520841)