NDC | 49967-384-01 |
Set ID | 49d5d9b0-06d4-4b91-bd22-c0983987557c |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
For sunscreen use:
● apply generously and evenly 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, cyclopentasiloxane, cyclohexasiloxane, glycerin, pheny trimethicone, polyglyceryl-4 isostearate, hexyl laurate, cetyl PEG/PPG-10/1 dimethicone, disteardimonium hectorite, pentylene glycol, moringa pterygosperma seed extract, triethanolamine, trihydroxystearin, silica, alumina, aluminum hydroxide, magnesium sulfate, alcohol denat., ascorbyl gluycoside, disodium stearoyl glutamate, acetylated glycol stearate, panthenol, castanea sativa (chestnut) seed extarct, tocopheryl acetate, methylparaben, phenoxyethanol, diazolidinyl urea, linalool, geraniol, alpha-isomethyl ionone, citronellol, benzyl alcohol, benzyl salicylate, fragrance; may contain: titanium dioxide, iron oxides
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANCOME PARIS BB BIENFAIT TEINTE BEAUTY BALM BROAD SPECTRUM SPF 30 SUNSCREEN
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-384 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 58 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-384-01 1 in 1 CARTON 08/01/2013 1 50 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 08/01/2013 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc. 076693183 pack(49967-384) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-384)