Label: TOTAL WHITE BRIGHTENING - octinoxate and hydroquinone cream
- NDC Code(s): 53218-002-02, 53218-002-03, 53218-002-04
- Packager: YZY Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
Ethylhexyl Methoxycinnamate 3%
Hydroquinone 2% ............................... Skin LightenerClose
Ethylhexyl Methoxycinnamate 3% ..... Sunscreen
Gradually fades skin discolorations in dark areas, age spots, freckles, liver spots and dark areas that can occur while using oral contraceptivesClose
For external use onlyClose
- Do Not Use
To prevent sunburn • On inflamed or broken skinClose
- When using this product
• Mild irritation may occurClose
• Avoid contact with eyes. If contact occurs rinse with water.
• Avoid unnecessary sun exposure and use a sunscreen or protective clothing
- Stop use and consult a doctor if
• A gradual blue-black darkening of the skin ocursClose
• Irritation becomes severe
• No improvement is seen after 3 months
- If pregnant or breast feeding,
consult a health professional before use.Close
- Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a poison control center immediately.Close
• If skin is sensitive, test on a small area inside the elbow overnight before use.Close
• adults and children 12 years and older apply as a thin layer to affected area twice daily or as directed by a doctor.
• Children under 12 years of age ask a doctor before use.
- Inactive ingredients
Water (Aqua), Coco-Caprylate/Caprate, Stearic Acid, PEG-8, Cetyl Alcohol, Stearyl Stearate, Glyceryl Stearate, PEG-100, Propylene Glycol, Kojic Acid, Daucus Carota Sative (Carrot) Seed Oil, Vaccinium Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Pentetic Acid, Zea Mays (Corn) Oil, Xanthan Gum, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Beta-Carotene, Sodium Sulfite, Sodium Metabisulfite, Tetrasodium EDTA, Methylparaben, Propylparaben, DMDM Hydantoin, Fragrance (Parfum)Close
- PRINCIPAL DISPLAY PANEL
Brightening Body Cream
Natural Bio-vegetal Activation
With Carrot Oil
8 OZ e 227 g Distributed by Heaven Scent, Miami FL
Tottenham, London N17 OQT, UK
MADE IN USA
Brightening Body Cream
Total White Brightening Cream diminishes the appearance of dark spots and skin discolorations caused by acne, aging, sun damage and pregnancey. This rich cream is formulated with Carrot Oil and Vitamins A and E; it effectivly moisturizes and nourishes your skin, while it protects from future damage. It safely brightens and evens dark spots for younger, healthier, more radiant looking skin.
Total White Brightening Body Cream diminishes the appearance of dark spots and skin discolorations caused by acne, aging, sun damage, and pregnancy. This rich cream is formulated with Carrot Oil and Vitamins A and E, it effectively moisturizes and nourishes your skin, while it protects against future damage. It safely brightens and evens dark spots for younger, healthier more radiant looking skin.
Total White Brightening Body Cream With carrot oil Lightens SkinNatural Bio-Vegetal Activator
- INGREDIENTS AND APPEARANCE
TOTAL WHITE BRIGHTENING
hydroquinone, ethylhexyl methoxycinnamate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53218-002 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 3 g in 100 g Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 2 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Coco-caprylate/caprate (UNII: 8D9H4QU99H) Stearic Acid (UNII: 4ELV7Z65AP) Polyethylene Glycol 400 (UNII: B697894SGQ) Cetyl Alcohol (UNII: 936JST6JCN) Stearyl Stearate (UNII: 5WX2EGD0DK) Glyceryl Monostearate (UNII: 230OU9XXE4) Propylene Glycol (UNII: 6DC9Q167V3) Kojic Acid (UNII: 6K23F1TT52) Carrot Seed Oil (UNII: 595AO13F11) Pentetic Acid (UNII: 7A314HQM0I) Corn Oil (UNII: 8470G57WFM) Xanthan Gum (UNII: TTV12P4NEE) .alpha.-tocopherol Acetate (UNII: 9E8X80D2L0) Vitamin A Palmitate (UNII: 1D1K0N0VVC) .beta.-carotene (UNII: 01YAE03M7J) Sodium Sulfite (UNII: VTK01UQK3G) Sodium Metabisulfite (UNII: 4VON5FNS3C) Edetate Sodium (UNII: MP1J8420LU) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Dmdm Hydantoin (UNII: BYR0546TOW) Polyethylene Glycol 4500 (UNII: TVH7653921) Sugarcane (UNII: 81H2R5AOH3) Orange (UNII: 5EVU04N5QU) Lemon (UNII: 24RS0A988O) Bilberry (UNII: 9P2U39H18W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53218-002-02 227 g in 1 JAR 2 NDC:53218-002-03 454 g in 1 JAR 3 NDC:53218-002-04 50 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/10/2012 Labeler - YZY Inc (174375659)