ELTAMD UV SPF46- zinc oxide and octinoxate sunscreen spray

EltaMD UV SPF46 by

Drug Labeling and Warnings

EltaMD UV SPF46 by is a Otc medication manufactured, distributed, or labeled by EltaMD, Inc., Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a physician if rash occurs

Hard surfaces may become damp when product is sprayed.  Avoid slips or falls

If product is swallowed, get medical help or contact a Poison Control Center right away

Keep out of reach of children.

080170933

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.

Directions

Shake Well before use

apply liberally 15 minutes before sun exposure.  Do not apply in windy conditions.  To open, push sliding lock on sprayer neck.  Hold bottle upright with nozzle 2-3 inches from skin.  Squeeze trigger to dispense product.  Apply liberally and evenly until product is visible on skin.  Gently rub in.  Do not spray into face.  Spray into hand and apply to face.  Use in well ventilated areas.

Reapply:

   after 80 minutes of swimming or sweating

   immediately after towel drying

   at least every 2 hours

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 an other sun protection measures including:

   limit time in the sun, expecially from 10 am - 2 pm

   wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: Ask a physician

Active Ingredients

Zinc Oxide   9.0%

Octinoxate   7.5%

Incactive Ingredients

butylene glycol, capryloyl glycine, cyclopentasiloxane, dimethicone, dimethicone/PEG-10/15 crosspolymer, dimethicone/vinyl diemthicone crosspolymer, lauryl PEG-9 polymethylsiloxyethyl dimethicone, phenoxyethanol, purified water, sodium chloride, triethoxycaprylylsilane, undecylenoyl glycine

Other information

protect this product from excessive heat and direct sun

Questions or Comments

Questions or Comments

Call toll free 1-800-633-8872

UVSPF46UC.jpg

INGREDIENTS AND APPEARANCE

ELTAMD UV SPF46 
zinc oxide and octinoxate sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2585
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	93 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2585-4	113 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/10/2018

Labeler - EltaMD, Inc. (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2585)