TIZO SHEER BOTANICALS NON-TINTED- titanium dioxide, zinc oxide cream 
Fallien Cosmeceuticals, 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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Drug Facts

Active Ingredients:

Titanium Dioxide 3.0%

Zinc Oxide 10%

Purpose:

Sunscreen

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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the 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 80 minutes of swimming or sweating
 
- Immediately after towel drying
 
- At least every 2 hours

Inactive Ingredients:

Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Olefira (Green Tea) Leaf Extract, Capric/Caprylic Triglyceride, Glyceryl Caprylate, Glyceryl Undecylenate, Melissa Officinalis (Balm Mint) Extract, Olive Oil Polyglyceryl-6 Esters, Polyglyceryl-6 Pentaoleate, Polyhydroxystearic Acid, Propanediol, Rosemarinus Officinalis (Rosemary) Extract, Salvia Officinalis (Sage) Leaf Extract, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Esters, Sodium Chloride, Sodium Stearoyl Glutamate, Tetradecane, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Water

Other Information:

Principal Display Panel – Carton Label

MINERAL
PROTECTION

TIZO®

SHEER BOTANICALS

NON-TINTED
SPF 45

Plant Based
Mineral Sunscreen

For Body & Face

Titanium & Zinc Oxides

Antioxidants C & E

Broad Spectrum SPF 45

Water Resistant (80 minutes)

Net Wt. 4 oz/113 g

Principal Display Panel – Carton Label

Principal Display Panel – Tube Label

MINERAL
PROTECTION

TIZO®

SHEER BOTANICALS

NON-TINTED
SPF 45

Plant Based
Mineral Sunscreen

For Body & Face

Titanium & Zinc Oxides

Antioxidants C & E

Broad Spectrum SPF 45

Water Resistant (80 minutes)

Net Wt. 4 oz/113 g

Principal Display Panel – Tube Label
TIZO SHEER BOTANICALS NON-TINTED 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPANEDIOL (UNII: 5965N8W85T)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SAGE (UNII: 065C5D077J)  
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
1-TETRADECENE (UNII: FW23481S7S)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-108-041 in 1 CARTON04/15/2019
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/15/2019
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-108)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-108) , PACK(58892-108)

Revised: 1/2021
Document Id: ef21cd49-ad5b-4a87-afef-829ac55d855a
Set id: 50a470bb-9968-402a-9603-5130a56b62ad
Version: 2
Effective Time: 20210112
 
Fallien Cosmeceuticals, LTD