REMAN HOMME SUN PROTECTION- titanium dioxide, zinc oxide, octinoxate stick

REMAN HOMME SUN PROTECTION by

Drug Labeling and Warnings

REMAN HOMME SUN PROTECTION by is a Otc medication manufactured, distributed, or labeled by Pf Nature. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 9.7%, Zinc Oxide 7.55%, Ethylhexyl Methoxycinnamate 7%

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

Purpose: UVA/UVB Protection

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

Keep out of reach of children:
Please keep this product out of the reach of babies and children.

INDICATIONS & USAGE

Indication and usage:
Please close the cap after use. Once it is unpacked, please use them up immediately as it dries up quickly.
Please do not keep this product in places with very high or low temperatures.
And please keep it out of direct sunlight.

DOSAGE & ADMINISTRATION

Dosage and administration:
After using basic goods, apply the product to forehead and nose in T shape, and cheeks in U shape. Then spread evenly with fingers and pat.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REMAN HOMME SUN PROTECTION 
titanium dioxide, zinc oxide, octinoxate stick

Product 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)