ELTAMD UV DAILY HYDRATION- octisalate, zinc oxide sunscreen lotion

EltaMD UV Daily Hydration by

Drug Labeling and Warnings

EltaMD UV Daily Hydration 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

Octisalate 5.0% Sunscreen
Zinc Oxide 11.0% Sunscreen

Indications and Usage

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

Purpose

Sunscreen

Directions

Apply liberally 15 minutes before sun exposure. [Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.] [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.

Inactive Ingredients

water, petrolatum, isopropyl palmitate, butyloctyl salicylate, ethylhexyl methocycrylene, cetearyl alcohol, diemthicone, phenoxyethanol, oleth-3 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-20 methyl glycose sesquisearate, polyisobutene, cetearyl glycoside, pongamia pinnata seed extract, polyether-1 tocopheryl acetate, carnosine, ethylhexylglycerin, bisabolol, tocopherol, PEG-7 trimethylolpropane coconut ether, phospohoric acid, sodium hyaluronate, citric acid, canola oil, triethoxycprylylsilane, zingiber officinale (ginger) root extract

Questions or Comments?

Call toll free 1-800-633-8872

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV DAILY HYDRATION 
octisalate, zinc oxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-6813
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	110 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
POLYETHER-1 (2800 MPA.S) (UNII: 6QR7NJP3G8)
CARNOSINE (UNII: 8HO6PVN24W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BISABOLOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CITRIC ACID (UNII: 2968PHW8QP)
CANOLA OIL (UNII: 331KBJ17RK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Product Characteristics
Color	yellow (light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-6813-1	48 g in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2025
2	NDC: 72043-6813-2	2 g in 1 PACKET; Type 0: Not a Combination Product	08/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/22/2025

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(72043-6813)