LA ROCHE POSAY NEW 50 BODY AND FACE SPF 50 MINERAL ANTHELIOS GENTLE 100 PERCENT MINERAL UV FILTERS SOFT FINISH WITH CELL OX SHIELD- titanium dioxide and zinc oxide lotion 
L'Oreal USA Products Inc

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Drug Facts

Drug Facts

Titanium dioxide 5%

Zinc Oxide 15%

Purpose

Sunscreen

Uses

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:

Other information

Inactive ingredients

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethylhexanoin, silica, poly C10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, diethylhexyl syringylidenemalonate, triethoxycaprylylsilane, aluminum hydroxide, stearic acid, aluminum stearate, chlorphnesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, tocopherol, p-ansic acid, capryloyl salicylic acid, xanthan gum, disodium EDTA, propylene carbonate, caprylic/capric triglyceride, cassia alata leaf extract, maltodextrin

Questions or comments?

1-888-LRP-LABO 1-888-577-5226

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

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LA ROCHE POSAY NEW 50 BODY AND FACE SPF 50 MINERAL ANTHELIOS GENTLE 100 PERCENT MINERAL UV FILTERS SOFT FINISH WITH CELL OX SHIELD 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TOCOPHEROL (UNII: R0ZB2556P8)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-091-01120 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
2NDC:49967-091-0290 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
3NDC:49967-091-035 mL in 1 PACKET; Type 0: Not a Combination Product12/15/2018
4NDC:49967-091-045 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
5NDC:49967-091-05150 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/15/2018
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC.185931458manufacture(49967-091)

Revised: 1/2024
Document Id: 5e3f83d1-03e6-4aff-b18c-5286ee1da034
Set id: c0f7ae46-7161-4d48-9386-007bfafecfd5
Version: 15
Effective Time: 20240101
 
L'Oreal USA Products Inc