NDC | 49967-899-01, 49967-899-02, 49967-899-03 |
Set ID | 6d3c5fc5-c818-46c4-8db3-cffcdcd56e06 |
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 generously 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hoursSun 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 meausures 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, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, C9-15 fluoroalcohol phosphate, tocopherol, phenoxyethanol, stearic acid, diethylhexyl syringylidenemalonate, PEG-9 polydimethylsiloxyethyl dimethcone, magnesium sulfate, PEG-8 laurate, PEG-9, polyhydroxystearic acid, maltodextrin, benzoic acid, iron oxides, propylene glycol, propylene carbonate, caprylyl glycol, disteardimonim hectorite, cassia alata leaf extract, alumina, aluminum hydroxide
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL SUNSCREEN
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-899 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 110 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) UNDECANE (UNII: JV0QT00NUE) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ISOHEXADECANE (UNII: 918X1OUF1E) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) NYLON-12 (UNII: 446U8J075B) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHENETHYL BENZOATE (UNII: 0C143929GK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIDECANE (UNII: A3LZF0L939) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DICAPRYLYL ETHER (UNII: 77JZM5516Z) TALC (UNII: 7SEV7J4R1U) ALUMINUM STEARATE (UNII: U6XF9NP8HM) PENTYLENE GLYCOL (UNII: 50C1307PZG) TOCOPHEROL (UNII: R0ZB2556P8) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARIC ACID (UNII: 4ELV7Z65AP) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM SULFATE (UNII: DE08037SAB) PEG-8 LAURATE (UNII: 762O8IWA10) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MALTODEXTRIN (UNII: 7CVR7L4A2D) BENZOIC ACID (UNII: 8SKN0B0MIM) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLENE CARBONATE (UNII: 8D08K3S51E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-899-01 1 in 1 CARTON 06/01/2012 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:49967-899-02 1 in 1 CARTON 06/01/2012 2 3 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-899-03 1 in 1 CARTON 06/01/2012 3 125 mL in 1 BOTTLE; 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 06/01/2012 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-899) , analysis(49967-899) Establishment Name Address ID/FEI Business Operations Interspray 364829903 pack(49967-899)