LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV HYDRA DAILY INVISIBLE BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 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, glycerin, c15-19 alkane, propanediol, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, panthenol, tocopherol, sodium stearoyl glutamate, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, sodium hyaluronate, pentylene glycol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, citric acid, caprylic/capric triglyceride, polyglycerin-3

Questions or comments?

1-888-LRP-LAB0 1-888-577-5226

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

image of a carton
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV HYDRA DAILY INVISIBLE BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-312
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) HOMOSALATE70 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
C15-19 ALKANE (UNII: CI87N1IM01)  
PROPANEDIOL (UNII: 5965N8W85T)  
PANTHENOL (UNII: WV9CM0O67Z)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-312-011 in 1 CARTON12/01/2023
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-312-021 in 1 CARTON12/01/2023
25 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/2023
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-312) , pack(49967-312)

Revised: 12/2023
Document Id: 4d92696f-4dcc-4d77-bed0-fdbc7db60733
Set id: cc61299b-5088-4cef-b90e-f5de67e46b25
Version: 2
Effective Time: 20231228
 
L'Oreal USA Products Inc