OTC Medication Information: Ultra Light Sunscreen Broad Spectrum SPF 50 Merle Norman

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

carton
(click image for full-size original)

tube
(click image for full-size original)

ULTRA LIGHT SUNSCREEN

BROAD SPECTRUM SPF 50

Merle Norman

Established in Los Angeles since 1931

113 g NET WT. 4 OZ.

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.39 g in 113 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 11.3 g in 113 g
OCTISALATE (OCTISALATE) OCTISALATE 5.65 g in 113 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3.11 g in 113 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 6.78 g in 113 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
BUTYLOCTYL SALICYLATE
PENTYLENE GLYCOL
GLYCERIN
SILICON DIOXIDE
POTASSIUM CETYL PHOSPHATE
DIMETHICONE
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE
POLYISOBUTYLENE (1000 MW)
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE
XANTHAN GUM
EDETATE DISODIUM
BUTYLATED HYDROXYTOLUENE
METHYLISOTHIAZOLINONE
CAPRYLYL GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57627-117-02 1 TUBE in 1 CARTON contains a TUBE (57627-117-01)
1 NDC:57627-117-01 113 g in 1 TUBE This package is contained within the CARTON (57627-117-02)
2 NDC:57627-117-04 1 TUBE in 1 CARTON contains a TUBE (57627-117-03)
2 NDC:57627-117-03 28 g in 1 TUBE This package is contained within the CARTON (57627-117-04)
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 Operations
Merle Norman Cosmetics 008479388 manufacture (57627-117)

Revised: 01/2020 Merle Norman Cosmetics

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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