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

PDP

TIEGE HANLEY DAILY MOISTURIZER SPF20 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-3700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) octinoxate0.055 kg  in 1 kg
avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) avobenzone0.025 kg  in 1 kg
octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) octocrylene0.02 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-3700-00.022 kg in 1 TUBE; Type 0: Not a Combination Product11/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/201604/16/2019
Labeler - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-3700) , label(52261-3700) , pack(52261-3700)

Revised: 3/2018
Document Id: 4a21cd15-ab30-439f-aca8-3a58af08cdb6
Set id: bfd85e25-a5e2-40e2-b2cf-923003487f73
Version: 3
Effective Time: 20180327
 
Cosco International, Inc.