Label: REMAN HOMME SUN PROTECTION- titanium dioxide, zinc oxide, octinoxate stick
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Contains inactivated NDC Code(s)
NDC Code(s): 69226-010-01 - Packager: Pf Nature
- 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 September 30, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Cetyl Ethylhexanoate, Mica, Hexyl Laurate, Phenyl Trimethicone, Dimethicone, Methyl Methacrylate Crosspolymer, Nylon-12, Synthetic Wax, Ceresin, Ricinus Communis (Castor) Seed Oil, Sorbitan Olivate, Cetyl Palmitate, Ethylene/Propylene Copolymer, Sorbitan Sesquioleate,
Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sorbitan Palmitate, Sorbitan Stearate, sucrose distearate, Stearalkonium Hectorite, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Propylene Carbonate, Tocopheryl Acetate, Tropolone, BHT, CI 77492, Argania Spinosa Kernel Oil, Zizania Aquatica Extract, CI 77491, Amber Powder, Amethyst Powder, Nephrite Powder, Pearl Powder, Tourmaline, Ruby Powder, Phenoxyethanol - PURPOSE
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WARNINGS
Warnings:
1. When the use of this cosmetic product causes the following side effects, you should stop using it. If you continue to use it, those side effects can worsen. So, you should consult a dermatologist about them.
a. Side effects such as red spots, swelling, pruritus and stimulation can occur when using this product.
b. The above side effects can occur on the applied part due to direct sunlight.
2. Please do not put this cosmetic product on wounded or damaged skin due to eczema and dermatitis.
3. When it gets into your eyes, please wash it off immediately with clean water. - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REMAN HOMME SUN PROTECTION
titanium dioxide, zinc oxide, octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69226-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.13 g in 22 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.66 g in 22 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.54 g in 22 g Inactive Ingredients Ingredient Name Strength Mica (UNII: V8A1AW0880) Dimethicone (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69226-010-01 22 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/30/2014 Labeler - Pf Nature (689060371) Registrant - Pf Nature (689060371) Establishment Name Address ID/FEI Business Operations Pf Nature 689060371 manufacture(69226-010)
