Label: SHEER DEFENSE TINTED MOISTURIZER BROAD SPECTRUM SPF 15 M50 MERLE NORMAN- octinoxate, titanium dioxide liquid
- NDC Code(s): 57627-153-01, 57627-153-02
- Packager: Merle Norman Cosmetics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 27, 2020
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ACTIVE INGREDIENT
Active Ingredients Purpose
Octinoxate7.5% Sunscreen
Titanium Dioxide 4.19% 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:
limiting time in the sun, especially from 10 a.m. - 2p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months: ask a doctor
Inactive ingredients:
Water (Aqua), Dimethicone, Butylene Glycol, Glyceryl Stearate SE, Mica, Talc, Iron Oxides, Glyceryl Dilaurate, Glyceryl Behenate, Ceramide 3, Saccharide Isomerate, Allantoin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Glycine Soja (Soybean) Germ Extract, Echinacea Purpurea Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Equisetum Arvense Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Oleifera Leaf Extract, Lecithin, Petrolatum, Palmitic Acid, Polyglyceryl-10 Decaoleate, Polyacrylamide, PEG-12 Dimethicone, octyldodecyl Stearoyl Stearate, Steareth-20, C13-14 Isoparaffin, Isocetyl Alcohol, Propylene Glycol, Laureth-7, Silica, Cyclodextrin, Disodium EDTA, Phenoxyethanol, Tetrasodium EDTA, BHT, Diazolidinyl Urea, Fragrance (Parfum)
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INGREDIENTS AND APPEARANCE
SHEER DEFENSE TINTED MOISTURIZER BROAD SPECTRUM SPF 15 M50 MERLE NORMAN
octinoxate, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-153 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.19 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) MICA (UNII: V8A1AW0880) TALC (UNII: 7SEV7J4R1U) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERYL DILAURATE (UNII: MFL3ZIE8SK) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) CERAMIDE 3 (UNII: 4370DF050B) SACCHARIDE ISOMERATE (UNII: W8K377W98I) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SOYBEAN GERM (UNII: JBW2VHD14M) ECHINACEA PURPUREA (UNII: QI7G114Y98) FENNEL SEED (UNII: G3QC02NIE6) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) CHAMOMILE (UNII: FGL3685T2X) CUCUMBER (UNII: YY7C30VXJT) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PETROLATUM (UNII: 4T6H12BN9U) PALMITIC ACID (UNII: 2V16EO95H1) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) STEARETH-20 (UNII: L0Q8IK9E08) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ISOCETYL ALCOHOL (UNII: 1800H64066) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LAURETH-7 (UNII: Z95S6G8201) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE SODIUM (UNII: MP1J8420LU) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-153-02 1 in 1 CARTON 12/10/2012 1 NDC:57627-153-01 35 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 not final part352 12/10/2012 Labeler - Merle Norman Cosmetics, Inc. (008479388) Registrant - Merle Norman Cosmetics, Inc. (008479388) Establishment Name Address ID/FEI Business Operations Merle Norman Cosmetics, Inc. 008479388 manufacture(57627-153)
