LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion 
Cosmetique Active Production

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 5%

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:
● shake well

● apply liberally 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, silica, dimethicone, niacinamide, PEG-100 stearate, glyceryl stearate, stearic acid, allantoin, ceramide 3, dimethicone/vinyl dimethicone crosspolymer, sodium hydroxide, myristic acid, myristyl alcohol, palmitic acid, ammonium polyacryloyldimethyl taurate, disodium EDTA, capryloyl glycine, caprylyl glycol, citric acid, xanthan gum, t-butyl alcohol, cetyl alcohol, tocopherol

Questions or comments?

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

image of a carton

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69625-583
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) HOMOSALATE50 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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ALLANTOIN (UNII: 344S277G0Z)  
CERAMIDE 3 (UNII: 4370DF050B)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
PALMITIC ACID (UNII: 2V16EO95H1)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69625-583-011 in 1 CARTON12/21/201612/21/2016
175 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69625-583-022 mL in 1 PACKET; Type 0: Not a Combination Product12/21/2016
3NDC:69625-583-033 mL in 1 TUBE; Type 0: Not a Combination Product12/21/2016
4NDC:69625-583-041 in 1 CARTON12/12/2022
4100 mL in 1 TUBE; Type 0: Not a Combination Product
5NDC:69625-583-051 in 1 CARTON12/21/201606/01/2026
575 mL in 1 TUBE; Type 0: Not a Combination Product
6NDC:69625-583-061 in 1 CARTON01/01/2024
640 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/21/2016
Labeler - Cosmetique Active Production (282658798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(69625-583) , pack(69625-583)
Establishment
NameAddressID/FEIBusiness Operations
Socoplan276221405pack(69625-583)

Revised: 4/2024
Document Id: ac7275a0-234a-4918-befd-5e2a0d6c1133
Set id: f9645435-e138-45df-a5ec-6dc7b3ff792d
Version: 3
Effective Time: 20240408
 
Cosmetique Active Production