DERMABLEND PROFESSIONAL SKINPERFECTOR REDNESS REDUCING PRIMER SUNSCREEN- avobenzone, octisalate and octocrylene lotion

Dermablend Professional SkinPerfector Redness Reducing Primer Sunscreen by

Drug Labeling and Warnings

Dermablend Professional SkinPerfector Redness Reducing Primer Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2%

Octisalate 3.3%

Octocrylene 4.6%

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 of 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, niacinamide, diisopropyl sebacate, dimethicone, sucrose tristearate, cyclohexasiloxane, ammonium polyacryloyldimethyl taurate, methylsilanol/silicate crosspolymer, ascorbyl glucoside, polysorbate 61, sodium stearoyl glutamate, phenoxyethanol, PEG-12 dimethicone, dimethiconol, caffeine, sodium benzoate, sodium citrate, xanthan gum, caprylyl glycol, disodium EDTA, sodium hydroxide, citric acid, yellow 5, blue 1

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMABLEND PROFESSIONAL SKINPERFECTOR REDNESS REDUCING PRIMER SUNSCREEN 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-105
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	33 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	46 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
POLYSORBATE 61 (UNII: X9E1MY2JQG)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
CAFFEINE (UNII: 3G6A5W338E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-105-01	1 in 1 CARTON	03/01/2013
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-105)