ELTAMD SKINCARE UV AOX ELEMENTS SPF50 TINTED- titanium dioxide, zinc oxide sunscreen lotion

EltaMD Skincare UV AOX Elements SPF50 Tinted by

Drug Labeling and Warnings

EltaMD Skincare UV AOX Elements SPF50 Tinted 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.

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.

Purpose

Sunscreen

Active Ingredients

Titanium Dioxide 4.4%
Zinc Oxide 13.5%

Keep out of reach of children

Keep out of reach of children

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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.

Other information:

Protect this product from excessive heat and direct sun.

QUESTIONS

call toll free 1-800-633-8872

Inactive ingredients

Water, Dimethicone, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, cetyl dimethicone, dimethicone PEG-10/15 crosspolymer,Polyhydroxystearic Acid, alumina, phenoxyethanol, iron oxides, Triethoxycaprylylsilane, sodium chloride, hydrogen dimethicone, sodium hyaluronate, potassium sorbate, Tocopheryl Acetate, tocopherol, bisabolol, carnosine, dipropylene glycol, ascorbyl palmitate, soidum citrate, canola oil, zingiber officinale (giner) root extract

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD SKINCARE UV AOX ELEMENTS SPF50 TINTED 
titanium dioxide, zinc oxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2519
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	44 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	135 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROGEN DIMETHICONE (30 CST) (UNII: JF2ZJ6R2WD)
HYALURONIC ACID (UNII: S270N0TRQY)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
CARNOSINE (UNII: 8HO6PVN24W)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CANOLA OIL (UNII: 331KBJ17RK)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2519-1	48 g in 1 TUBE; Type 0: Not a Combination Product	11/14/2023
2	NDC: 72043-2519-2	2 g in 1 PACKET; Type 0: Not a Combination Product	11/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/14/2023

Labeler - CP Skin Health Group, Inc (611921669)

Registrant - CP Skin Health Group, Inc (611921669)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2519)