TIEGE HANLEY MOISTURIZING LIP BALM SPF 30- zinc oxide stick 
Raining Rose, 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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Tiege Hanley Moisturizing Lip Balm SPF 30

Drug Facts

Active Ingredients
Zinc Oxide 7.5%

Purpose

Sunscreen

Uses • Helps prevent sunburn and chapped lips

Warnings
For External Use OnlyDo 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 Poison Control Center right away.
Keep out of reach of children.

Directions •Apply generously 15 minutes before sun exposure
• Reapply at least every two hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months ask a doctor

Other Information: Protect this product from excessive
heat and sun. This product is sealed with a tamper
evident label. Do not use if label is missing or broken.

Inactive Ingredients Pentaerythrityl Tetraisostearate, Oryza Sativa (Rice) Bran Wax, Prunus Amygdalus Dulcis
(Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Glyceryl Stearate, Squalene, Behenyl
Alcohol, Moringa Oleifera Seed Oil, Caprylic/Capric Triglyceride, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia
Chinensis (Jojoba) Seed Oil, Citrus Reticulata Blanco (Tangerine) Oil, Polyhydroxystearic Acid, Undaria Pinnatifida
Extract, Mentha Piperita (Peppermint) Oil

Package Labeling

TIEGE

HANLEY

Uncomplicated

Skin Care for Men​®

LIP

Moisturizing Lip Balm

with SPF 30

Net Wt 0.15 oz (4.2 g)

Made in the USA

MFD for Tiege Hanley LLC

Chuicago, IL 60612

Tiege.com

Tube Label

331758 Tube

Box Label

Tieg-Henly Box

res

TIEGE HANLEY MOISTURIZING LIP BALM SPF 30 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-1004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
RICE BRAN (UNII: R60QEP13IC)  
ALMOND OIL (UNII: 66YXD4DKO9)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SQUALENE (UNII: 7QWM220FJH)  
DOCOSANOL (UNII: 9G1OE216XY)  
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
JOJOBA OIL (UNII: 724GKU717M)  
MANDARIN OIL (UNII: NJO720F72R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-1004-11 in 1 PACKAGE04/01/2020
14.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/28/2020
Labeler - Raining Rose, Inc. (083819404)
Registrant - Raining Rose, Inc. (083819404)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose, Inc.083819404manufacture(65692-1004) , label(65692-1004) , pack(65692-1004)

Revised: 4/2020
Document Id: 4198ba52-509a-4ac1-a891-fd4f6887b5ed
Set id: c5574cfd-5b96-4036-8704-2c058dca5db3
Version: 1
Effective Time: 20200413
 
Raining Rose, Inc.