LANCOME PARIS IMANANCE BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate and titanium dioxide lotion 
L’Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Octinoxate 6%

Titanium dioxide 3.4%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

protect the product in this container from excessive heat and direct sun

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?

1-800-LANCOME (1-800-526-2663)

Monday - Friday (9 a.m. - 5 p.m. EST)

image of a label

LANCOME PARIS IMANANCE BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE34 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-058-011 in 1 CARTON12/01/201005/17/2021
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/201005/17/2021
Labeler - L’Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L’Oreal USA, Inc.185931458manufacture(49967-058)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc.076693183pack(49967-058)

Revised: 1/2023
 
L’Oreal USA Products Inc