LA ROCHE POSAY REDERMIC C UV SUNSCREEN- avobenzone, octisalate and octocrylene 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

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

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

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.

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 he sun

Purpose

Sunscreen

Other information

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

- store at 20 - 25 C (68 to 77 F)

Questions or comments?

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

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

Inactive ingredients

water, isononyl isononanoate, glycerin, mannose, ascorbic acid, dimethicone, diisopropyl sebacate, silica, sucrose tristearate, pentylene glycol, potassium hydroxide, polysorbate 61, PEG-12 dimethicone, madecassoside, dimethiconol, sodium stearoyl glutamate, ammonium polyacryloyldimethyl taurate, disodium EDTA, hydrolyzed hyaluronic acid, caprylyl glycol, acetyl dipeptide-1 cetyl ester, xanthan gum, fragrance

image of a carton

LA ROCHE POSAY REDERMIC C UV SUNSCREEN 
avobenzone, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-728
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 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)  
MANNOSE, D- (UNII: PHA4727WTP)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE TRISTEARATE (UNII: 71I93STU5M)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POLYSORBATE 61 (UNII: X9E1MY2JQG)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-728-011 in 1 CARTON12/01/201208/16/2019
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/201208/16/2019
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(49967-728)

Revised: 1/2023
 
L'Oreal USA Products Inc