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

Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40 by

Drug Labeling and Warnings

Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40 by is a Otc medication manufactured, distributed, or labeled by Samhealthyskin.COM LLC, Art Nouveau. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40

Active ingredient

Titanium Dioxide 10%

Purpose

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.

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 doctor if 

• rash occurs

Keep out of reach of children.

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

Directions

For sunscreen use

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

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:

• Limit time in the sun, especially from 10 a.m.– 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses

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)

INGREDIENTS AND APPEARANCE

SAMHEALTHYSKIN B.B. SUNSCREEN BROAD SPECTRUM SPF 40  
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57650-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57650-159-79	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/25/2013

Labeler - Samhealthyskin.COM LLC (067387798)

Registrant - Samhealthyskin.COM LLC (067387798)

Establishment
Name	Address	ID/FEI	Business Operations
Art Nouveau		557796198	manufacture(57650-159)