SUNSCREEN LIP BALM SPF 30- zinc oxide stick

Sunscreen Lip Balm SPF 30 by

Drug Labeling and Warnings

Sunscreen Lip Balm SPF 30 by is a Otc medication manufactured, distributed, or labeled by Salt and Stone LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Non-Nano Zinc Oxide 8%

Purpose:

Sunscreen

Uses:

Helps Prevent Sunburn

Warnings:

For external use only

Do 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.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions:

Apply liberally 15 minutes before sun exposure  Use a water resistant sunscreen if swimming or sweating  Reapply at least every 2 hours  Children under 6 months of age: Ask a doctor.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including . Limit time in the sun, especially from 10am - 2pm . Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

Prunus Amygdalus Dulcis (Sweet Almond) Oil*, Butyrospermum Parkii (Shea) Butter*, Cera Alba (Beeswax)*, Simmondsia Chinensis (Jojoba) Seed Oil*, Caprylic/capric Triglyceride, Euphorbia Cerifera (Candelilla) Wax*, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil*, Copernicia Cerifera (Carnauba) Wax*, Tocopherol, Bisabolol, Glyceryl Caprylate, Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Glyceryl Undecylenate. *Organic Ingredient.

Other Information:

Protect this product from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNSCREEN LIP BALM SPF 30 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
WHITE WAX (UNII: 7G1J5DA97F)
JOJOBA OIL (UNII: 724GKU717M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CANDELILLA WAX (UNII: WL0328HX19)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGAN OIL (UNII: 4V59G5UW9X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)

Product Characteristics
Color	white	Score
Shape	ROUND	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-120-00	4.3 g in 1 CONTAINER; Type 0: Not a Combination Product	06/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/15/2019

Labeler - Salt and Stone LLC (080683697)