ELTAMD UV ACTIVE- zinc oxide, titanium dioxide sunscreen cream

EltaMD UV Active by

Drug Labeling and Warnings

EltaMD UV Active 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. Stop use and ask physician if rash occurs. When using this product keep out of eyes. Rinse with water to remove. 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.

Active Ingredients

Zinc Oxide   19.0%   Sunscreen

Titanium Dioxide   4.0%   Sunscreen

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

Apply liberally 15 minutes before sun exposure. Reapply after 80 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, regularly use sunscreen with a broad-spectrum SPF value of 15 or higher. Limit time in the sun, especially from 10 am to 2 pm. Wear long sleeved shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

Questions

Questions or Comments?

1-800-633-8872

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

water, caprylic/capric trigylceride, coco-caprylate/caprate, ethyl macadamiate, glycerin, sorbitan olivate, polyglyceryl-6 polyricinoleate, C15-19 alkane, hydrogenated polyisobutene, sodium chloride, triethoxycaprylylsilane, silica, glyceryl beheanate, hydroxyacetophenone, polyglyceryl-2 isostearate, polyhydroxysearic acid, disteardimonium hectorite, 1,2-hexanediol, caprylyl glycol, hydrolyzed jojoba esters, xanthan gum, diemthicone, sclerotium gum, trisodium ethylenediamine disuccinate, lecithin, pullulan, jojoba esters, polygonum aviculare extract, tocopherol, malic acid 

UV Active Artwork.jpg

INGREDIENTS AND APPEARANCE

ELTAMD UV ACTIVE 
zinc oxide, titanium dioxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	190 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PULLULAN (UNII: 8ZQ0AYU1TT)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
glycerin (UNII: PDC6A3C0OX)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
TOCOPHEROL (UNII: R0ZB2556P8)
MALIC ACID (UNII: 817L1N4CKP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
C15-19 ALKANE (UNII: CI87N1IM01)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2600-3	90 g in 1 TUBE; Type 0: Not a Combination Product	02/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/03/2020

Labeler - EltaMD Skincare, Inc. (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2600)