LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 4.7%

Octisalate 5%

Octocrylene 7%

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 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, isononyl isononanoate, glycerin, dimethicone, aluminum starch octenylsuccinate, sucrose tristearate, polymethylsilsesquioxane, polysorbate 61, PEG-12 dimethicone, carbomer, triethanolamine, dimethiconol, sodium hyaluronate, sodium stearoyl glutamate, disodium EDTA, hydrolyzed hylauronic acid, caprylyl glycol, xanthan gum, sodium benzoate, phenoxyethanol, fragrance

Questions or comments?

1-888-LRP-LABO  1888-577-5226

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

image of a carton

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE47 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SUCROSE TRISTEARATE (UNII: 71I93STU5M)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
POLYSORBATE 61 (UNII: X9E1MY2JQG)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-126-011 in 1 CARTON09/01/201209/01/2012
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-126-021 in 1 CARTON09/01/2012
250 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/2012
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(49967-126) , pack(49967-126)

Revised: 1/2024
Document Id: 4a222f05-8c59-4f1d-b10b-497925401248
Set id: ad4f45b2-3391-4e32-9744-28838727260c
Version: 4
Effective Time: 20240101
 
L'Oreal USA Products Inc