ELTA MD SKINCARE UV STICK BROAD SPECTRUM SPF50- zinc oxide stick

Elta MD Skincare UV Stick Broad Spectrum by

Drug Labeling and Warnings

Elta MD Skincare UV Stick Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by CP Skin Health Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 22.0%

Purpose

Sunscreen

Uses

•   helps prevent sunburn
• if used as directed with other sun protection measures (see ​Directions​),  decreases the risk of UV damage 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 physician

if rash 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
reapply: after 80 minutes of swimming or sweating: immediately after towel drying: at lear every 2 hours
Sun Protection Measures

Spending time in the sun can increase your riske of skin cancer and early skin aging.
To decrease this risk regularly use a sunscreen with a broad spectrum SPF 15 of 15 or higher and other sun protection measures including:

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:Ask a physician

Other Information

• Protect this product from excessive heat and direct sun

Inactive ingredients

Caprylic/Capric Triglyceride, Helianthys Annuus (Sunflower) Seed Wax, Cerearyl Nonanoate, Theobroma Cacao Cocoa) Seed Butter, Butyloctyl Salicylate, Lauryl Laurate, Polyhydroxystearic Acid, Euphorbia Cerifera (Candelilla) Was, Capryloyl Glycerin/Sebacic Acid Copolymer, Mica, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Oryzanol, Ethyl Ferulate, Isostearic Acid, Lecithin, Polyglyceryl-3 Plyricinoleate, Bisabolol, Tocopherol, Silica

PRINCIPAL DISPLAY PANEL

elta MD® Skincare

UV STICK

BROAD-SPECTRUM SPF 50+

net wt 1.3oz (37 g)

INGREDIENTS AND APPEARANCE

ELTA MD SKINCARE UV STICK BROAD SPECTRUM  SPF50
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-0495
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
COCOA BUTTER (UNII: 512OYT1CRR)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LAURYL LAURATE (UNII: GPW77G0937)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
MICA (UNII: V8A1AW0880)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
SHEA BUTTER (UNII: K49155WL9Y)
ORYZANOL (UNII: SST9XCL51M)
ETHYL FERULATE (UNII: 5B8915UELW)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-0495-2	1 in 1 CARTON	12/01/2021
1	NDC: 72043-0495-1	37 g in 1 CYLINDER; 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	12/01/2021

Labeler - CP Skin Health Group, Inc (611921669)