PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43- sunscreen lotion

Private Label Moisturizing Oil Free Paraben Free SPF43 by

Drug Labeling and Warnings

Private Label Moisturizing Oil Free Paraben Free SPF43 by is a Otc medication manufactured, distributed, or labeled by 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.  Stope use and ask doctor if rash occurs. When using the product keep out of eyes; rinse with water to remove.  Keep out of reach of children.  If swallowed, get medical help or contact poison control immediately.  Protect this product from excessive heat and direct sun.

Uses

Helps prevent sunbrun an dphoto damage caused by UVA/UVB exposure.  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.

Active Ingredients

Zinc Oxide   7.50%

Octinoxate   7.50%

Octisalate   2.50%

Keep out of reach of children

Keep out of reach of children.

Directions

Apply liberally 15 minutes before exposure to the sun.  Use a water resistant sunscreen if swimming or sweating.  Reapply at least every 2 hours.  Children under 6 months of age, ask physician.  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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m.  Wear long-sleeved shirts, pants, hats and sunglasses.

Other Ingredients

Water, Isopropyl Palmitate, Octyl Stearate, Ethylhexyl Isononanoate, Cylcopentasiloxane, Cetearyl Glucoside, Dimethicone, Glycerth-26, Sodium Hyaluronate, Panthenol, Allantoin, Tocopheryl Acetate, Ascorbyl Palmitate, Oleth-3 Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylopropane Coconut Ether, Polyether-1, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylysilane

Labeling

INGREDIENTS AND APPEARANCE

PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60232-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	75 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75   in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	25   in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERETH-26 (UNII: NNE56F2N14)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYL STEARATE (UNII: 772Y4UFC8B)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
HYALURONIC ACID (UNII: S270N0TRQY)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60232-0007-1	50 g in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/07/2010

Labeler - Swiss-American CDMO, LLC (080170933)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(60232-0007)