NDC | 49967-058-01 |
Set ID | bd91d1a2-014c-40a3-b388-730c401f6dbe |
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, rosa canina fruit oil, elaeis guineensis (palm) oil, ethylene/acrylic acid copolymer, propylene glycol, glycerin, hydrogenated lecithin, PEG-5 rapeseed sterol, panthenol, stearic acid, carbomer, triethanolamine, sodium hyaluronate, helianthus annuus (sunflower) seed oil, aluminum hydroxide, aluminum starch octenylsuccinate, guanosine, disodium EDTA, retinyl palmitate, tocopheryl acetate, methylparaben, propylparaben, butylparaben, diazolidinyl urea, fragrance, linalool, alpha-isomethyl ionone, hydroxycitronellal, hydroxyisohexyl 3-cyclohexene carboxaldehyde, citronellol, butylphenyl methylpropional, hexyl cinnamal, benzyl alcohol, benzyl benzoate, benzyl cinnamate; may contain: titanium dioxide, iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANCOME PARIS IMANANCE BROAD SPECTRUM SPF 15 SUNSCREEN
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-058 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 60 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 34 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) PALM OIL (UNII: 5QUO05548Z) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) PEG-5 RAPESEED STEROL (UNII: NS80WJS6KK) PANTHENOL (UNII: WV9CM0O67Z) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SUNFLOWER OIL (UNII: 3W1JG795YI) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) GUANOSINE (UNII: 12133JR80S) EDETATE DISODIUM (UNII: 7FLD91C86K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) LINALOOL, (+/-)- (UNII: D81QY6I88E) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL BENZOATE (UNII: N863NB338G) BENZYL CINNAMATE (UNII: V67O3RO97U) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-058-01 1 in 1 CARTON 12/01/2010 1 50 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 12/01/2010 Labeler - L’Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L’Oreal USA, Inc. 185931458 manufacture(49967-058) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc. 076693183 pack(49967-058)