NDC | 49967-409-01, 49967-409-02 |
Set ID | eb43177e-389d-4572-8521-ee4d0a2dad3a |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
- shake well before 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
-
Inactive ingredients
water, isododecane, dimethicone, C12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, iron oxides, aluminum stearate, PEG-8 laurate, phenoxyethanol, magnesium sulfate, caprylyl glycol, alumina, polyhydroxystearic acid, disteardimonium hectorite, tocopherol, propylene carbonate, benzoic acid, disodium stearoyl glutamate, PEG-9
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPERFLUID UV MINERAL DEFENSE BROAD SPECTRUM SPF 50 PLUS SUNSCREEN
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-409 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 150 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) UNDECANE (UNII: JV0QT00NUE) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) NYLON-12 (UNII: 446U8J075B) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHENETHYL BENZOATE (UNII: 0C143929GK) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ISOHEXADECANE (UNII: 918X1OUF1E) TRIDECANE (UNII: A3LZF0L939) DICAPRYLYL ETHER (UNII: 77JZM5516Z) TALC (UNII: 7SEV7J4R1U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) PENTYLENE GLYCOL (UNII: 50C1307PZG) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) FERRIC OXIDE RED (UNII: 1K09F3G675) ALUMINUM STEARATE (UNII: U6XF9NP8HM) PEG-8 LAURATE (UNII: 762O8IWA10) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLENE CARBONATE (UNII: 8D08K3S51E) BENZOIC ACID (UNII: 8SKN0B0MIM) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-409-01 1 in 1 CARTON 12/01/2015 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-409-02 1 in 1 CARTON 12/01/2015 2 5 mL in 1 TUBE; 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 12/01/2015 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-409)