Label: PATRICIA WEXLER SKIN BRIGHTENING DAILY MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 28- avobenzone, octinoxate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62670-8042-6, 62670-8042-9 - Packager: Bath & Body Works, 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 August 28, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
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DIRECTIONS
- 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
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INACTIVE INGREDIENTS
Water (Aqua, Eau), Butylene Glycol, Isostearyl Neopentanoate, Cetearyl Alcohol, Myristyl Nicotinate, Glycerin, Cyclopentasiloxane, Hydrogenated Lecithin, Arctostaphylos Uva Ursi Leaf Extract, Betula Alba Bark Extract, Morus Alba Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cinnamomum Cassia Bark Extract, Glycine Soja (Soybean) Seed Extract, Rheum Palmatum Root/Stalk Extract, Arbutin, Ascorbyl Glucoside, Tetrahexyldecyl Ascorbate, Urea, Sucrose, Xanthan Gum, Trehalose, Phospholipids, Sodium Hyaluronate, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Chrysin, Isononyl Isononanoate, Pentaerythrityl Tetraethylhexanoate, Cetearyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysilicone-11, Dipotassium Glycyrrhizate, Steareth-20, Cyclohexasiloxane, Polyquaternium-51, Dimethylcyclohexylethoxy Isobutylpropanoate, Ethyl 2,2-Dimethylhydrocinnamal, Delphone, N-Hydroxysuccinimide, Sodium PCA, Carbomer, Triethanolamine, Methyldihydrojasmonate, Disodium EDTA, Cyclamen Aldehyde, Triacetin, Phenoxyethanol, Chlorphenesin, Methylparaben, Propylparaben, Butylparaben, Ethylparaben, Benzoic Acid, Isobutylparaben, Mica, Titanium Dioxide (CI 77891), Orange 4 (CI 15510), Yellow 5 (CI 19140), Red 4 (CI 14700).
- COMPANY INFORMATION
- PRODUCT PACKAGING
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INGREDIENTS AND APPEARANCE
PATRICIA WEXLER SKIN BRIGHTENING DAILY MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 28
avobenzone, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62670-8042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.8 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62670-8042-6 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:62670-8042-9 15 mL in 1 JAR; 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 08/28/2013 Labeler - Bath & Body Works, Inc. (878952845) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging, LLC 809172885 manufacture(62670-8042) Establishment Name Address ID/FEI Business Operations Accel inc. 838933430 relabel(62670-8042)
