ALL WEATHER SPF 15 LIP BALM- zinc oxide stick

ALL WEATHER SPF 15 LIP BALM by

Drug Labeling and Warnings

ALL WEATHER SPF 15 LIP BALM by is a Otc medication manufactured, distributed, or labeled by Burt's Bees. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE 11%

PURPOSE

Sunscreen

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only

Do not use on damaged or broken skin.

When using this product keep out of reach of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Reappy after 40 minutes of swimming or weating.

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measuresincluding:

limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Children under 6 months consult a doctor.

Inactive Ingredients:

beeswax, olea europaea (olive) fruit oil, theobroma cacao (cocoa) seed butter, simmondsia chinensis (jojoba) seed oil, isoamyl laurate, butyrospermum parkii (shea) butter, flavor, limnanthes alba (meadowfoam) seed oil, citrus aurantium dulcis (orange) peel wax, jojoba esters, glycine soja (soybean) oil, tocopherol, citric acid, rebaudioside A, polyhydroxystearic acid

Other Information:

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

BURTS BEES

ALL WEATHER SPF 15

MOISTURIZING LIP BALM

INGREDIENTS AND APPEARANCE

ALL WEATHER SPF 15 LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
SHEA BUTTER (UNII: K49155WL9Y)
ORANGE PEEL WAX (UNII: 0U715N387C)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-036-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2017
2	NDC: 26052-036-02	1 in 1 CARTON	12/01/2017
2	NDC: 26052-036-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 26052-036-03	1 in 1 CARTON	12/01/2017
3	NDC: 26052-036-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 26052-036-04	2 in 1 CARTON	12/01/2017
4	NDC: 26052-036-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 26052-036-05	4 in 1 CARTON	12/01/2017
5	NDC: 26052-036-01	4.25 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 final	part352	12/01/2017

Labeler - Burt's Bees (613480946)