ELTAMD UV PHYSICAL SPF41- zinc oxide and titanium dioxide sunscreen cream

EltaMD UV Physical SPF41 by

Drug Labeling and Warnings

EltaMD UV Physical SPF41 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.

Active Ingredients

Zinc Oxide   9.0%   Sunscreen

Titanium Dioxide   7.0%   Sunscreen

Purpose

Sunscreen

Indications & 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.

Keep out of reach of children

Keep out of reach of children

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 40 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

Inactive Ingredients

water, isopropyl palmitate, ethylkhexyl stearate, octyldodecyl neopentanoate, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, hydrogenated polyisobutene, triehtoxycaprylylsilane, oleth-3 phosphate, tocopheryl acetate, bisabolol, tocopherol, carnosine, ethylhexylglycerin, sorbitan isostearate, polysorbate 20, zingiber officinale (ginger) root extract, iron oxides

Questions or Comments?

Call toll free 1-800-633-8872

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV PHYSICAL SPF41 
zinc oxide and titanium dioxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2588
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	90 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
PHOSPHORIC ACID (UNII: E4GA8884NN)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TOCOPHEROL (UNII: R0ZB2556P8)
CANOLA OIL (UNII: 331KBJ17RK)
CARNOSINE (UNII: 8HO6PVN24W)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2588-3	85 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2024
2	NDC: 72043-2588-2	2 g in 1 PACKET; Type 0: Not a Combination Product	08/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/05/2024

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(72043-2588)