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EltaMD UV PhysicalSPF 41 SPF 41

Dosage form: lotion
Ingredients: Zinc Oxide 90g in 1000g, Titanium Dioxide 70g in 1000g
Labeler: Swiss-American Products
NDC Code: 60232-2578

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

EltaMD UV Physical SPF 41

Active Ingredients Purpose

Zinc Oxide 9.0%...........UVA/UVB Sunscreen
Titanium Dioxide 7.0%..UVA/UVB Sunscreen

INDICATION: EltaMD UV Physical SPF 41 is a chemical free sunscreen, specially formulated for the most sensitive skin. It is a tinted, gentle daily sunscreen that provides excellent UVA and UVB protection. EltaMD UV Physical absorbs quickly and can be used on the face, either alone or under makeup. It is non-comedogenic , contains no parabens, and is sensitivity and fragrance free.

EltaMD UV Physical uses 9% transparent micronized zinc oxide and 7% titanium dioxide to provide very strong protection from the UVA (aging rays, thought to be a major cause of early wrinkles and skin cancer) and provides an SPF 41 to protect from the UVB (burning) rays. It is ideal for sensitive or traumatized skin, post photodynamic therapy (PDT), and in conjunction with photosensitizing medications or treatments, and safe for children.

Warnings

For external use only.

- Avoid direct contact with the eyes.

- Discontinue use if signs of irritation appear.

- Children under 6 months of age, consult your doctor.

Directions

Apply liberally before exposure to the sun. Reapply every 2-3 hours to maintain protection.

Inactive Ingredients
Alpha Tocopheryl, Aluminum Hydroxide, Butylene Glycol, Citric Acid, Dimethicone/Methicone Copolymer, Hydrated Silica, Iodopropynyl Butylcarbamate, Iron Oxide, Isopropyl Palmitate, Lecithin, Linoleic Acid, Octyl Stearate, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, Perfluorononyl Dimethicone, Phenoxyethanol, Polyacrylate 13/Polyisobutene/Polysorbate 20, Purified Water, Quercitin, Retinyl Palmitate, Sodium Hydroxide, Sodium Selenite, Thioctic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane

ELTAMD UV PHYSICALSPF 41   SPF 41
eltamd uv physical spf 41 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-2578
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide90 g  in 1000 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide70 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL 
Aluminum Hydroxide 
Butylene Glycol 
CITRIC ACID MONOHYDRATE 
DIMETHICONE 
METHICONE (20 CST) 
Hydrated Silica 
Iodopropynyl Butylcarbamate 
Isopropyl Palmitate 
LECITHIN, SOYBEAN 
Linoleic Acid 
Octyl Stearate 
Octyldodecyl Neopentanoate 
Oleth-3 Phosphate 
Phenoxyethanol 
POLYISOBUTYLENE (1000 MW) 
Polysorbate 20 
water 
QUERCETIN 
vitamin a palmitate 
Sodium Hydroxide 
Sodium Selenite 
ferric oxide yellow 
ferric oxide red 
brown iron oxide 
FERROSOFERRIC OXIDE 
.alpha.-lipoic acid 
ALPHA-TOCOPHEROL ACETATE 
Triethoxycaprylylsilane 
Packaging
#Item CodePackage Description
1NDC:60232-2578-385 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/30/2002
Labeler - Swiss-American Products (611921669)
Registrant - Swiss-American Products (611921669)
Establishment
NameAddressID/FEIOperations
Swiss-American Products611921669manufacture

Revised: 07/2009
 
Swiss-American Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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