LIP BALM SPF- octinoxate, zinc oxide stick

Lip Balm SPF by

Drug Labeling and Warnings

Lip Balm SPF by is a Otc medication manufactured, distributed, or labeled by Harry's, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

LIP BALM SPF 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70533-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70533-002-57	1 in 1 CARTON	04/03/2016
1		5.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2016

Labeler - Harry's, Inc. (079239206)