ELTAMD UV DAILY TINTED- octinoxate, zinc oxide sunscreen lotion

EltaMD UV Daily Tinted by

Drug Labeling and Warnings

EltaMD UV Daily 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.

Active ingredients

Octinoxate 7.5% Sunscreen
Zinc Oxide 9.0% 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.

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. 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.

Other information:

Protect this product from excessive heat and direct sun.

Inactive ingredients

water, petrolatum, isopropyl palmitate, dimethicone, cetearyl alcohol, oleth-3 phosphate, phenoxyethanol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, cetearyl glucoside, polyether-1, butylene glycol, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, iodopropynyl butylcarbamate, citric acid, tocopheryl acetate, triethoxycaprylylsilane, iron oxides

Questions?

Call toll free 1-800-633-8872

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV DAILY TINTED 
octinoxate, zinc oxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-6806
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	900 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	750 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYALURONIC ACID (UNII: S270N0TRQY)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-6806-2	2 g in 1 PACKET; Type 0: Not a Combination Product	05/31/2024
2	NDC: 72043-6806-1	48 g in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/31/2024

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(72043-6806)