ELTAMD UV AOX ELEMENTS- zinc oxide, titanium dioxide sunscreen lotion

EltaMD UV AOX Elements by

Drug Labeling and Warnings

EltaMD UV AOX Elements by is a Otc medication manufactured, distributed, or labeled by CP Skin Health Group, 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 a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating.  Reapply 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 and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Active Ingredients

Titanium Dioxide 4.4% Sunscreen
Zinc Oxide 13.5% Sunscreen

Keep out of reach of children

Keep out of reach of children

Inactive Ingredients

water, dimethicone, butyloctyl salicylate, octyldodecyl neopentanoate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, cetyl dimethicone, dimethicone/PEG-10/15 crosspolymer, polyhydroxystearic acid, alumina, phenoxyethanol, triethoxycaprylylsilane, sodium chloride, hydrogen dimethicone, sodium hyaluronate, potassium sorbate, tocopheryl acetate, tocopherol, bisabolol, carnosine, dipropylene glycol, ascorbyl palmitate, zingiber officinate (ginger) root extract, iron oxides

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-800-633-8872

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELTAMD UV AOX ELEMENTS 
zinc oxide, titanium dioxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2522
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	135.1 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	44.3 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CARNOSINE (UNII: 8HO6PVN24W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BISABOLOL (UNII: 24WE03BX2T)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
TOCOPHEROL (UNII: R0ZB2556P8)
CANOLA OIL (UNII: 331KBJ17RK)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALUMINA (UNII: LMI26O6933)
HYDROGEN DIMETHICONE (45 CST) (UNII: L2AFM6S5VW)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2522-1	48 g in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2025
2	NDC: 72043-2522-2	2 g in 1 PACKET; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2025

Labeler - CP Skin Health Group, Inc (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2522)