TIEGE HANLEY AM MORNING FACIAL MOISTURIZER WITH SPF 20- avobenzene, octinoxate, octocrylene lotion

Tiege Hanley AM Morning Facial Moisturizer with SPF 20 by

Drug Labeling and Warnings

Tiege Hanley AM Morning Facial Moisturizer with SPF 20 by is a Otc medication manufactured, distributed, or labeled by TIEGE HANLEY, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Avobenzene 2.5%
Octinoxate 5.5%
Octocrylene 2.0%

PURPOSE

SUNSCREEN

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions
■ After washing your face, massage a pea-sized
amount into entire face and neck in a gentle circular motion
■ Before sun exposure, use a broad-spectrum sunscreen of SPF
15 or higher
■ Reapply sunscreen at least every two hours
■ Use a water-resistant sunscreen if swimming or sweating
■ For children under 6 months, ask a doctor

INDICATIONS & USAGE

Uses ■ Helps prevent sunburn

INACTIVE INGREDIENT

Water

Isodecyl Neopentanoate

Cyclopentasiloxane

Bis-PEG-12 Dimethicone Beeswax

Glycerin

Glyceryl Stearate

PEG-100 Stearate

Phenoxyethanol

Hydroxypropyl Starch Phosphate

C18-38 Alkyl Hydroxystearoyl Stearate

Caprylyl Glycol

Carbomer

Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

Isohexadecane

Lavandula Angustifolia (Lavender) Oil

Rosmarinus Officinalis (Rosemary) Leaf Oil

Sodium Hydroxide

Polysorbate 80

Calendula Officinalis Flower Extract

Plantago Major Leaf Extract

Disodium EDTA

Tiege Hanley AM Morning Facial Moisturizer with SPF 20 - 0.75 FL. OZ. / 22mL

Tiege Hanley AM Morning Facial Moisturizer with SPF 20 - 2.5 FL. OZ. / 75mL

INGREDIENTS AND APPEARANCE

TIEGE HANLEY AM MORNING FACIAL MOISTURIZER WITH SPF 20 
avobenzene, octinoxate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71714-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TETRADECYLOCTADECYL STEARATE (UNII: VX3T5G31XA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71714-001-22	22 mL in 1 TUBE; Type 0: Not a Combination Product	09/30/2017
2	NDC: 71714-001-75	75 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 Drug	M020	09/30/2017

Labeler - TIEGE HANLEY, Inc (080305325)