TIEGE HANLEY AM MORNING FACIAL MOISTURIZER WITH SPF20- octinoxate, avobenzone, and octocrylene lotion

Tiege Hanley AM Morning Facial Moisturizer with SPF20 by

Drug Labeling and Warnings

Tiege Hanley AM Morning Facial Moisturizer with SPF20 by is a Otc medication manufactured, distributed, or labeled by Tiege hanley, Solo Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
EthylMethoxycinnamate 5.5%	Sunscreen
Butyl Methoxydibenzoylmethane 2.5%	Sunscreen
Octocrylene 2.0%	Sunscreen

Uses

Helps prevent sunburn. If used as directed with Other sun protection measures, decreases the risk of skin cancer and early skin aging cause by sun.

Warnings

For External Use Only. Avoid contact with Eyes. Discontinue use if skin irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

After washing your face, massage a pea-sized amount into entire face and neck in a gentle (yet masculine) circular motion. For detailed usage tips, visit: www.tiege.com/tips

Inactive Ingredients

Aqua, Isocecyl Neopentanoate, Cyclopentasiloxane, Bis-PEG-12 Dimethicone Beeswax, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Sodium Hydroxide, HydroxypropylStarch Phosphate, C18-38 Alkyl Hydroxystearoyl Stearate, Sodium Acrylate, Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80 , Calendula Officinalis Flower Extract, Plantago Major Leaf Extract, Carbomer, Disodium EDTA, Lavandula Officinalis ( Lavender) Oil, Rosmarinus Officinalis ( Rosemary) Leaf Oil

PRINCIPAL DISPLAY PANEL - 22 mL Tube Label

TIÉGE
HANLEY

Uncomplicated Skin Care for Men™

AM

Morning Facial
Moisturizer with SPF 20

0.75 FL. OZ. / 22mL

INGREDIENTS AND APPEARANCE

TIEGE HANLEY AM MORNING FACIAL MOISTURIZER WITH SPF20 
octinoxate, avobenzone, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71714-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	55 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	25 mg  in 1 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TETRADECYLOCTADECYL STEARATE (UNII: VX3T5G31XA)
Caprylyl Glycol (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Glycerin (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ISOHEXADECANE (UNII: 918X1OUF1E)
Lavender Oil (UNII: ZBP1YXW0H8)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ROSEMARY OIL (UNII: 8LGU7VM393)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71714-020-22	22 mL in 1 TUBE; Type 0: Not a Combination Product	09/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/30/2017

Labeler - Tiege hanley (080305325)

Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
BMC 1092, Inc. dba Solo Laboratories, Inc		078831987	MANUFACTURE(71714-020) , PACK(71714-020)