ACTIVE INGREDIENTS:

Titanium Dioxide 8%

Zinc Oxide 3.8%

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.

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
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:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18-Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

OTHER INFORMATION:

Protect this product from excessive heat and direct sun
May stain some fabrics
Cleanse thoroughly at nighttime
PA+++

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 40

Mineral Based
Facial Sunscreen

Free of Chemical Sunscreens
Water-Resistant (80 Minutes)
Broad Spectrum
Unscented
Oil and PABA Free

Tinted

Net. Wt. 1.8 oz./ 53 g

Principal Display Panel – 53 g Bottle Label

HUTTON KLEIN HK DERMATOLOGISTS SPF 40 MINERAL BASED FACIAL SUNSCREEN TINTED
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81679-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	80 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	38 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone 20 (UNII: H8YMB5QY0D)
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)
Brown Iron Oxide (UNII: 1N032N7MFO)
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81679-203-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/17/2017

Labeler - Hutton, Kathleen MD (792310955)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(81679-203)

Name	Address	ID/FEI	Business Operations
Establishment
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(81679-203) , PACK(81679-203)

DRUG FACTS