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

SPF 50 Mineral Based Facial Sunscreen by

Drug Labeling and Warnings

SPF 50 Mineral Based Facial Sunscreen by is a Otc medication manufactured, distributed, or labeled by Hutton, Kathleen MD, Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Stop use and ask a doctor if rash occurs.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
• Children under 6 months: Ask a doctor
• 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 am-2 pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses

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:

• Protect this product from excessive heat and direct sun
• May stain some fabrics

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

• Free of Chemical Sunscreens
• Water-Resistant (40 Minutes)
• Broad Spectrum
• Oil and PABA Free

Net. Wt. 1.8 oz./ 53 g

INGREDIENTS AND APPEARANCE

SPF 50 MINERAL BASED FACIAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81679-258
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	100 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81679-258-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/25/2024

Labeler - Hutton, Kathleen MD (792310955)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(81679-258)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(81679-258) , PACK(81679-258)