LIP BALM SPF- octinoxate, zinc oxide stick 
Harry's, 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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Lip Balm SPF 15

Drug Facts

Active ingredients

Octinoxate 7.5%

Zinc Oxide 6.0%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown only to help prevent sunburn, not skin cancer or early aging.

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash or irritation occurs

Keep out of reach of children.

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

Directions

• apply liberally 15 minutes before sun exposure • re-apply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • children under 6 months: ask a doctor

Inactive ingredients

Hydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Beeswax, C12-15 Alkyl Benzoate, C18-C70 Isoparaffin, Myristyl Myristate, Polyethylene, Flavor, Paraffin, Menthyl Lactate, Tocopheryl Acetate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Sodium Saccharin, Triethoxycaprylylsilane, Limonene, BHT, Linalool, Cucumis Sativus (Cucumber) Seed Extract, Citric Acid

Other information

Protect the product in this container from excessive heat and direct sun

Questions or comments?

Call 1-888-212-6855

Package Labeling:

Outer Label01Inner Label01

LIP BALM SPF 
octinoxate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70533-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
SHEA BUTTER (UNII: K49155WL9Y)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
CUCUMBER SEED (UNII: BT3S9L53JK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70533-002-571 in 1 CARTON04/03/2016
15.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2016
Labeler - Harry's, Inc. (079239206)

Revised: 4/2016
Document Id: 2fab0ad2-7443-53fc-e054-00144ff8d46c
Set id: 4e9784cf-ea7d-42e5-952c-27585f8614e6
Version: 2
Effective Time: 20160404
 
Harry's, Inc.