UV PROTECT FACE SPF 50- zinc oxide, titanium dioxide cream 
Naos USA, Inc.

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UV PROTECT FACE SPF 50

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 broken skin.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

rash occurs

Keep out reach of children.

If swallowed, call a poison control centre or get medical help right away.

Directions

Adults 18 years and older:

  • Apply liberally and evenly 15 minutes 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 (59-86ºF)
  • 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:

Outer Label2Inner Label2

UV PROTECT FACE SPF 50 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE88.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-011-001 in 1 BOX01/31/201809/30/2025
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/31/201809/30/2025
Labeler - Naos USA, Inc. (080727572)

Revised: 11/2023
Document Id: 0b41a486-6e39-a1a7-e063-6294a90ace21
Set id: 64431eff-e7a8-2a22-e053-2991aa0aecf9
Version: 6
Effective Time: 20231128
 
Naos USA, Inc.