ELTAMD UV REPLENISH BROAD SPECTRUM SPF44- zinc oxide, titanium dioxide lotion

EltaMD UV Replenish Broad Spectrum SPF44 by

Drug Labeling and Warnings

EltaMD UV Replenish Broad Spectrum SPF44 by is a Otc medication manufactured, distributed, or labeled by EltaMD Skincare, 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 water to remove

Stop use and ask physician if rash occurs

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

Keep out of reach of children

Keep out of reach of children

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

Active Ingredients

Zinc Oxide   10.0%

Titanium Dioxide   5.5%

Directions

Apply liberally 15 minutes before sun exposure

reapply: after 40 minutes of swimming or sweating

immediately after towel drying

at least every two hours

Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularyly use a sunscreen with a broad-spectrum SPF 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 uner 6 months: ask a physician

Inactive Ingredients

purified water, caprylic/capric triglyceride, C15-19 Alkane, Octyldodecyl neopentanoate, butyloctyl salicylate, cetyl dimethicone, hydrogenated polyisobutene, Mica, dimethicone, sorbitan olivate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, sodium chloride, phenoxyethanol, polyglyceryl-2 isostearate, disteardimonium hectorite, glycerin, xanthan gum, triethoxycaprylylsilane, euphorbia cerifera (Candelilla) wax, sodium hyaluronate, disodium EDTA, ethylhexyl glycerin, glyceryl behenate, silica, ascorbyl palmitate, tocopheryl acetate

Questions or Comments

call toll free 1-800-633-8872

Other information

Protect this product from excessive heat and direct sun

UV Replenish UC.jpg

INGREDIENTS AND APPEARANCE

ELTAMD UV REPLENISH BROAD SPECTRUM SPF44 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2514
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	55 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C15-19 ALKANE (UNII: CI87N1IM01)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
dimethicone (UNII: 92RU3N3Y1O)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
HYALURONIC ACID (UNII: S270N0TRQY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2514-2	57 g in 1 TUBE; Type 0: Not a Combination Product	07/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/26/2018

Labeler - EltaMD Skincare, Inc (611921669)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2514)