Tiege Hanley AM Morning Facial Moisturizer with SPF20: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

PRINCIPAL DISPLAY PANEL -- 22 mL Tube Label
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
octinoxate (octinoxate) octinoxate 55 mg in 1 mL
Avobenzone (Avobenzone) Avobenzone 25 mg in 1 mL
octocrylene (octocrylene) octocrylene 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BIS-PEG-12 DIMETHICONE (70 MPA.S)
CALENDULA OFFICINALIS FLOWER
TETRADECYLOCTADECYL STEARATE
Caprylyl Glycol
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
CYCLOMETHICONE 5
EDETATE DISODIUM ANHYDROUS
Glycerin
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)
ISODECYL NEOPENTANOATE
ISOHEXADECANE
Lavender Oil
PEG-100 STEARATE
PHENOXYETHANOL
PLANTAGO MAJOR LEAF
POLYSORBATE 80
ROSEMARY OIL
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
SODIUM HYDROXIDE
water
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71714-020-22 22 mL in 1 TUBE None
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 Operations
BMC 1092, Inc. dba Solo Laboratories, Inc 078831987 MANUFACTURE (71714-020), PACK (71714-020)

Revised: 01/2020 Tiege hanley

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