NDC | 49967-018-01 |
Set ID | cb18b102-ca13-4a5a-ba4f-6ae996b97a5e |
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:
● apply generously 15 minutes before sun exposure
● reapply:
● after 40 minutes of swimming or sweating
● immediately after towel drying
● at least every 2 hours
● 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, 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 gllycol, PEG-9 polydimethylsiloxyethyl dimethicone, iron oxides, alumina, polyhydroxystearic acid, phehoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, C9-15 fluoroalcohol phosphate, benzoic acid, PEG-9
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL BODY BROAD SPECTRUM SPF 50 ULTRA LIGHT SUNSCREEN
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-018 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) CYCLOMETHICONE 6 (UNII: XHK3U310BA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHENETHYL BENZOATE (UNII: 0C143929GK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIDECANE (UNII: A3LZF0L939) DICAPRYLYL ETHER (UNII: 77JZM5516Z) TALC (UNII: 7SEV7J4R1U) ALUMINUM STEARATE (UNII: U6XF9NP8HM) PENTYLENE GLYCOL (UNII: 50C1307PZG) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) FERRIC OXIDE RED (UNII: 1K09F3G675) ALUMINUM OXIDE (UNII: LMI26O6933) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAGNESIUM SULFATE (UNII: DE08037SAB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PEG-8 LAURATE (UNII: 762O8IWA10) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLENE CARBONATE (UNII: 8D08K3S51E) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-018-01 1 in 1 CARTON 06/01/2013 1 125 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 06/01/2013 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-018) , analysis(49967-018) Establishment Name Address ID/FEI Business Operations Interspray 364829903 pack(49967-018)