SPF 50 MINERAL BASED FACIAL SUNSCREEN- titanium dioxide, zinc oxide cream 
Hutton, Kathleen MD

----------

DRUG FACTS

ACTIVE INGREDIENTS:

Titanium Dioxide 10%

Zinc Oxide 3%

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:

INACTIVE INGREDIENTS:

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

OTHER INFORMATION:

MANUFACTURED FOR:
Kathleeen Hutton MD
Newport Beach, CA 92660

WWW.HUTTONKLEIN.COM
800-909-0060

Principal Display Panel – 53 g Bottle Label

HUTTON KLEIN
HK
DERMATOLOGISTS

SPF 50

Mineral Based
Facial Sunscreen

Net. Wt. 1.8 oz./ 53 g

Figure
SPF 50 MINERAL BASED FACIAL SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81679-258
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide100 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISODODECANE (UNII: A8289P68Y2)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81679-258-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/25/2024
Labeler - Hutton, Kathleen MD (792310955)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(81679-258)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(81679-258) , PACK(81679-258)

Revised: 3/2024
Document Id: d1612c94-e50e-4ba5-a591-a7dfa77fb5f8
Set id: 5cf0d2e3-d496-424c-ac75-70ff5b87e9ca
Version: 1
Effective Time: 20240325
 
Hutton, Kathleen MD