Label: SAMHEALTHYSKIN B.B. SUNSCREEN BROAD SPECTRUM SPF 40- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57650-159-79 - Packager: Samhealthyskin.COM LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 11, 2015
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- Official Label (Printer Friendly)
- Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
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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
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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)
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INGREDIENTS AND APPEARANCE
SAMHEALTHYSKIN B.B. SUNSCREEN BROAD SPECTRUM SPF 40
titanium dioxide creamProduct 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)
