DERMABLEND PROFESSIONAL LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 SUNSCREEN- octisalate and octocrylene lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Octisalate 3.2%

Octocrylene 6%

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 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, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Questions or comments?

1-877-900-6700

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

image of a carton

image of a carton
DERMABLEND PROFESSIONAL LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 SUNSCREEN 
octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-906
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ISODODECANE (UNII: A8289P68Y2)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALCOHOL (UNII: 3K9958V90M)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ISOBUTANE (UNII: BXR49TP611)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-906-011 in 1 CARTON01/01/2017
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2017
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax USA, Inc.010990210manufacture(49967-906)

Revised: 12/2023
Document Id: 8dd11291-42fb-4c43-99d3-f4219bf5aa03
Set id: df62e1c2-ce72-4ded-8985-156dce9ff41d
Version: 9
Effective Time: 20231227
 
L'Oreal USA Products Inc