ELTAMD UV CLEAR TINTED SPF46- zinc oxide and octinoxate sunscreen lotion

EltaMD UV Clear Tinted SPF46 by

Drug Labeling and Warnings

EltaMD UV Clear Tinted SPF46 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 the 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. Keep out of reach of children.

Active Ingredients

Zinc Oxide 9.0%   Sunscreen

Octinoxate 7.5%   Sunscreen

Uses

helps prevent sunburn. if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

apply liberally to face and neck 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 a.m. - 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses. children under 6 months: ask a physician

Inactive Ingredients

purified water, cyclopentasiloxane, nicacinamide, octyldodecyl neopentanoate, butylene glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, lactic acid, oleth-3 phosphate, phenoxyethanol, iodopropynyl butylcarbamate, isopropyl palmitate, octyl stearate, iron oxides, triethoxycaprylylsilane

UVCLEARTINTEDUC

INGREDIENTS AND APPEARANCE

ELTAMD UV CLEAR TINTED SPF46 
zinc oxide and octinoxate sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	90 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
LACTIC ACID (UNII: 33X04XA5AT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYL STEARATE (UNII: 772Y4UFC8B)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2520-1	48 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/10/2018

Labeler - EltaMD, Inc. (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2520)