Drug Facts

Active Ingredients

Zinc Oxide (Non-Nano) 8 %

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 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 a Poison Control Center immediately.

Directions

Apply liberally 15 minutes before sun exposure
Reapply:
• After 80 minutes of swimming or sweating • Immediately after towel drying •At Least every 2 hours
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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. Sun Protection Measures.
Children under 6 months: Ask a doctor

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea) Butter, Cera Flava (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Copernicia Cerifera (Carnauba) Wax, Tocopherol, Glycine Soja (Soybean) Oil, Bisabolol, GlycerylCaprylate, Glyceryl Undecylenate, Triethoxycaprylylsilane

image description

SALT AND STONE SUNSCREEN LIP BALM SPF 30
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71585-139
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.08 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
CANDELILLA WAX (UNII: WL0328HX19)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71585-139-00	4.3 g in 1 APPLICATOR; Type 0: Not a Combination Product	11/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/23/2020

Labeler - Salt and Stone LLC (080683697)

Salt & Stone Sunscreen Lip Balm SPF 30, 0.15 Oz.(4.3 g)