ELTAMD UV CLEAR BLEMISH-PRONE AND OIL BALANCING- octinoxate and zinc oxide sunscreen cream

EltaMD UV Clear Blemish-Prone and Oil Balancing by

Drug Labeling and Warnings

EltaMD UV Clear Blemish-Prone and Oil Balancing 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.

Keep out of reach of children

Keep out of reach of children

Active Ingredients

Octinoxate 3.5%

Zinc Oxide 11.0%

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. 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, dimethicone, niacinamide, octyldodecyl neopentanoate, ethylhexyl methoxycrylene, butyloctyl salicylate, hydroxyethyl acrylate/sodium acryloldimethicone taurate copolymer, phenoxyethanol, polyisobutlene, triethoxycaprylylsilane, tocopheryl acetate, carnosine, bisabolol, tocpherol, peg-7 trimethylolpropane coconut ether, pongamia pinnata seed extract, oleth-3 phosphate, lactic acid, canola oil, BHT, sodium hyaluronate, phosphoric acid, zingiber officinale (Ginger) root extract

Questions or comments?

Call toll free 1-800-633-8872

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV CLEAR BLEMISH-PRONE AND OIL BALANCING 
octinoxate and zinc oxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2518
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	110 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARNOSINE (UNII: 8HO6PVN24W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BISABOLOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
LACTIC ACID (UNII: 33X04XA5AT)
CANOLA OIL (UNII: 331KBJ17RK)
BHT (UNII: 1P9D0Z171K)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
PHOSPHORIC ACID (UNII: E4GA8884NN)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2518-1	48 g in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2026
2	NDC: 72043-2518-2	2 g in 1 PACKET; Type 0: Not a Combination Product	01/15/2026
3	NDC: 72043-2518-5	14 g in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2026

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(72043-2518)