SAMHEALTHYSKIN B.B. SUNSCREEN BROAD SPECTRUM SPF 40 - titanium dioxide cream 
Samhealthyskin.COM LLC

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.

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Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40

Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40


Active ingredient

Titanium Dioxide 10%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product


Stop use and ask a doctor if 

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

For sunscreen use

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 value of 15 or higher and other sun protection measures including:


Children under 6 months of age: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

WATER, MINERAL OIL, CYCLOMETHICONE, PROPYLENE GLYCOL, DIMETHICONE/PEG-10/15 CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, TALC, IRON OXIDES, HYALURONIC ACID, BEESWAX, MICROCRYSTALLINE WAX, SHEA (BUTYROSPERMUM PARKII) BUTTER, TRIBEHENIN, SORBITAN SESQUIOLEATE, SOLUBLE COLLAGEN, TOCOPHERYL ACETATE, ALLANTOIN, TEA (CAMELLIA SINENSIS) LEAF EXTRACT, WHITE MULBERRY (MORUS ALBA) BARK EXTRACT, LICORICE (GLYCYRRHIZA GLABRA) ROOT EXTRACT, DIPOTASSIUM GLYCYRRHIZATE, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, DISODIUM EDTA, RED GINSENG (PANAX GINSENG)EXTRACT, SODIUM CHLORIDE, FRAGRANCE

Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40 1.69oz/50ml (57650-159-79)

Outer

Inner

SAMHEALTHYSKIN B.B. SUNSCREEN BROAD SPECTRUM SPF 40  
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57650-159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYALURONIC ACID (UNII: S270N0TRQY)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
LICORICE (UNII: 61ZBX54883)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57650-159-7950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/25/2013
Labeler - Samhealthyskin.COM LLC (067387798)
Registrant - Samhealthyskin.COM LLC (067387798)
Establishment
NameAddressID/FEIBusiness Operations
Art Nouveau557796198manufacture(57650-159)

Revised: 8/2015
Document Id: dfee0bad-f3e1-42d2-a932-89e3e9e90fd9
Set id: 97a7e1b3-bd03-4d0e-9809-b2d03afd8bee
Version: 4
Effective Time: 20150811
 
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