ELTAMD UV PHYSICAL ROSY TINT SPF40- titanium dioxide, zinc oxide sunscreen lotion

EltaMD UV Physical Rosy Tint SPF40 by

Drug Labeling and Warnings

EltaMD UV Physical Rosy Tint SPF40 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

Titanium Dioxide   7.0%

Zinc Oxide    9.0%

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.

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.

Keep out of reach of children

Keep out of reach of children

Other Information

Protect this product from excessive heat and direct sun.

Inactive ingredients

water, isopropyl plamitate, ethylhexyl stearate, octyldodecyl neopentanoate, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, triethoxycaprylylsilane, oleth-3 phosphate, citric acid, tocopheryl acetate, bisabolol, tocopherol, ethylhexylglycerin, carnosine, polysorbate 20, sodium hydroxide, phosphoric acid, canola oil, zingiber officinale (ginger) root extract, iron oxides

Questions?

Call 1-800-633-8872

visit www.eltamd.com

labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV PHYSICAL ROSY TINT SPF40 
titanium dioxide, zinc oxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2257
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARNOSINE (UNII: 8HO6PVN24W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHOSPHORIC ACID (UNII: E4GA8884NN)
CANOLA OIL (UNII: 331KBJ17RK)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
POLYISOBUTYLENE (45000 MW) (UNII: YR8AQ94O31)

Product Characteristics
Color	pink (Rosy Tint)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2257-1	48 g in 1 TUBE; Type 0: Not a Combination Product	09/05/2024
2	NDC: 72043-2257-2	2 g in 1 PACKET; Type 0: Not a Combination Product	09/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/05/2024

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(72043-2257)