Drug Labeling and Warnings

Drug Details [pdf]

TIEGE HANLEY DAILY MOISTURIZER SPF20- octinoxate lotion 
Cosco International, Inc.

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.

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Active Ingredient

Active Ingredient                       Purpose
Octinoxate  5.5%.......................Sunscreen

Avobenzone 2.5%......................Sunscreen

Octocrylene 2.0%......................Sunscreen

Best Use:

After washing your face, massage a pea-sized amount into entire face and neck a gentle (yet masculine) circular mothin.

For detailed usage tips, visit:  www.tiege.com/tips

Caution:

For external use only.

Avoid contact with eyes.

Discontinue use if irritation occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

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

TIEGE HANLEY DAILY MOISTURIZER SPF20 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-3700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	octinoxate	0.055 kg  in 1 kg
avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	avobenzone	0.025 kg  in 1 kg
octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	octocrylene	0.02 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)	.724 kg  in 1 kg
isodecyl neopentanoate (UNII: W60VYE24XC)	0.047 kg  in 1 kg
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	0.03 kg  in 1 kg
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)	0.025 kg  in 1 kg
glycerin (UNII: PDC6A3C0OX)	0.02 kg  in 1 kg
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.0075 kg  in 1 kg
PEG-100 STEARATE (UNII: YD01N1999R)	0.0075 kg  in 1 kg
phenoxyethanol (UNII: HIE492ZZ3T)	0.006 kg  in 1 kg
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	0.0005 kg  in 1 kg
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)	0.0005 kg  in 1 kg
TETRADECYLOCTADECYL STEARATE (UNII: VX3T5G31XA)	0.005 kg  in 1 kg
lavender oil (UNII: ZBP1YXW0H8)	0.005 kg  in 1 kg
ROSEMARY OIL (UNII: 8LGU7VM393)	0.005 kg  in 1 kg
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.005 kg  in 1 kg
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)	0.005 kg  in 1 kg
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.0045 kg  in 1 kg
caprylyl glycol (UNII: 00YIU5438U)	0.004 kg  in 1 kg
sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 MW) (UNII: 1DXE3F3OZX)	0.00325 kg  in 1 kg
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)	0.002 kg  in 1 kg
isohexadecane (UNII: 918X1OUF1E)	0.0015 kg  in 1 kg
polysorbate 80 (UNII: 6OZP39ZG8H)	0.00025 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-3700-0	0.022 kg in 1 TUBE; Type 0: Not a Combination Product	11/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/15/2016	04/16/2019

Labeler - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-3700) , label(52261-3700) , pack(52261-3700)

Revised: 3/2018

Document Id: 4a21cd15-ab30-439f-aca8-3a58af08cdb6

34390-5

Set id: bfd85e25-a5e2-40e2-b2cf-923003487f73

Version: 3

Effective Time: 20180327