ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 MERLE NORMAN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Ultra Light Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Ultra Light Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients        Purpose

Avobenzone 3.0%       Sunscreen

Homosalate 10.0%      Sunscreen

Octisalate 5.0%           Sunscreen

Octocrylene 2.75%      Sunscreen

Oxybenzone 6.0%       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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

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.

Directions

For sunscreen use:

apply liberally and evenly 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

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: Ask a doctor

Inactive ingredients:

Water, Cyclopentasiloxane, Butyloctyl Salicylate, Pentylene Glycol, Glycerin, Silica, Potassium Cetyl Phosphate, Dimethicone, Hydrogenated Palm Glycerides, Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate, Polyisobutene, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Methyl Methacrylate Crosspolymer, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/Dimethicone Copolymer, Trimethylsiloxysilicate, Caprylyl/Capryl Glucoside, Xanthan Gum, Disodium EDTA, BHT, Methylisothiazolinone, Caprylyl Glycol, Fragrance

PRINCIPAL DISPLAY PANEL

ULTRA LIGHT SUNSCREEN

BROAD SPECTRUM SPF 50

Merle Norman

Established in Los Angeles since 1931

113 g NET WT. 4 OZ.

INGREDIENTS AND APPEARANCE

ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50  MERLE NORMAN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.39 g  in 113 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	11.3 g  in 113 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.65 g  in 113 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.11 g  in 113 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6.78 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-117-02	1 in 1 CARTON	03/29/2013
1	NDC: 57627-117-01	113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 57627-117-04	1 in 1 CARTON	11/30/2016
2	NDC: 57627-117-03	28 g 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 final	part352	03/29/2013

Labeler - Merle Norman Cosmetics (008479388)

Registrant - Merle Norman Cosmetics (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics		008479388	manufacture(57627-117)