ELTAMD UV LUMINOUS- titanium dioxide, zinc oxide sunscreen lotion

EltaMD UV Luminous by

Drug Labeling and Warnings

EltaMD UV Luminous 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.

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.

Keep out of reach of children

Keep out of reach of children

Active Ingredients

Titanium Dioxide 7.2% Sunscreen
Zinc Oxide 9.0% Sunscreen

Other information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

water, isopropyl palmitate, ethylhexyl stearate, octyldodecyl neopentanoate, perfluorononly dimethicone, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, triethoxycaprylylsilane, oleth-3 phosphate, citric acid, polysorbate 20, sorbitan isostearate, sodium hydroxide, thioctic acid, quercetin, tocopherol, iron oxides

Questions?

Call toll free 1-800-633-8872

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV LUMINOUS 
titanium dioxide, zinc oxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	72 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)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYL STEARATE (UNII: 772Y4UFC8B)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
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)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)
QUERCETIN (UNII: 9IKM0I5T1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2256-1	10 g in 1 TUBE; Type 0: Not a Combination Product	12/09/2020	11/14/2023
2	NDC: 72043-2256-7	48 g in 1 TUBE; Type 0: Not a Combination Product	12/09/2020
3	NDC: 72043-2256-3	30 g in 1 TUBE; Type 0: Not a Combination Product	12/09/2020	11/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/09/2020

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(72043-2256)