THEFACESHOP NATURAL SUN OIL-FREE SUNSCREEN BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion 
THEFACESHOP Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50

ACTIVE INGREDIENTS

Zinc Oxide 11.65%

Octinoxate 7.00%

Titanium Dioxide 4.57%

Octisalate 4.5%

Ensulizole 3.5%

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

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if rash 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 and as needed.
  • Reapply as needed or after towel drying, 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. to 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PANTHENOL, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, STEARIC ACID, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, HELIANTHUS ANNUS (SUNFLOWER) SRPOUT EXTRACT, MENTHYL PCA, SODIUM PCA, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891), FRAGRANCE

OTHER INFORMATION

Protect this product from excessive heat and direct sun

QUESTIONS OR COMMENTS?

Call toll free 1-888-498-9004

PRINCIPAL DISPLAY PANEL

NATURAL SUN
OIL-FREE SUNSCREEN

BROAD SPECTRUM
SPF 50

1.69 fl. oz. 50 mL

natural sun oil free

THEFACESHOP NATURAL SUN OIL-FREE SUNSCREEN BROAD SPECTRUM SPF 50 
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-195
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.825 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.285 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ZINC STEARATE (UNII: H92E6QA4FV)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TROMETHAMINE (UNII: 023C2WHX2V)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51523-195-012 in 1 BOX01/01/201805/31/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/201805/31/2021
Labeler - THEFACESHOP Co., Ltd. (688329416)
Establishment
NameAddressID/FEIBusiness Operations
fmg Co.Ltd690188305manufacture(51523-195)

Revised: 12/2021
Document Id: d320c37b-2f42-ebe0-e053-2995a90a43e9
Set id: 75b29ea6-109d-3591-e053-2991aa0a3829
Version: 3
Effective Time: 20211201
 
THEFACESHOP Co., Ltd.