Label: BIOWHITE RESILIENT MASSAGE- dimethicone cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated January 11, 2012
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
Water, Argania Spinosa Kernel Oil, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii(Shea Butter), Beeswax, Cethyl Ethylhexanoate (CEH), Olea Europaea (Olive) Fruit Oil, Butylene Glycol, Macadamis Ternifolia Seed Oil, Glycerin, Limnanthes Alba (Meadowfoam) Seed Oil, Hydrolyzed Pea Protein, Lecithin, Phytosterols, Stearyl Alcohol, Polysorbate 60, Hydrogenated Coconut Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Stearic Acid, Bisabolol, Triethanolamine, Sorbitan Sesquiolate, Phenoxyethanol, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sericin, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Methyl Paraben, Chaenomeles Sinensis Fruit Extract, Allantoin, Ceramide3, Hydrogenated Lecithin, Caprylic/Capric Triglyceride, Disodium EDTA, Xanthan Gum, Tourmaline, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite, Sodium Hyaluronate, Sea Water, Butylated Hydroxytoluene(BHT), Flavor
In case of having following symptoms after using this, you're advised to stop using it immediately.
If you keep using it, the symptoms will get worse and need to consult a dermatologist.
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.
In case of getting it into your eyes, you have to wash it immediately.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
DOSAGE & ADMINISTRATION
Dosage and administration:
Apply after washing face.
Take a small amount of cream about 1.0g-1.5g onto the fingertips and gently massage over the entire face.(cheeks, nostrils, mouth corners, forehead, and the around of eyes, even your hands)
Blot face lightly with tissue, and may sleep without washing it.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BIOWHITE RESILIENT MASSAGE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44781-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 4.27 g in 95 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARGAN OIL (UNII: 4V59G5UW9X) SQUALANE (UNII: GW89575KF9) JOJOBA OIL (UNII: 724GKU717M) SHEA BUTTER (UNII: K49155WL9Y) YELLOW WAX (UNII: 2ZA36H0S2V) OLIVE OIL (UNII: 6UYK2W1W1E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYSORBATE 60 (UNII: CAL22UVI4M) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SOYBEAN OIL (UNII: 241ATL177A) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44781-210-01 95 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/01/2011 Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147) Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147) Establishment Name Address ID/FEI Business Operations ZION SYNTHETIC FIBER CO., LTD. 688011147 manufacture