Label: TOTAL WHITE BRIGHTENING - octinoxate and hydroquinone lotion
- NDC Code(s): 53218-001-01
- 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 Lotion
Natural Bio-vegetal Activation
With Carrot Oil
16 FL. OZ e 473 mL
Distributed by Heaven Scent, Miami FL
Tottenham, London N17 OQT, UK
MADE IN USA
Total White Brightening Body Lotion diminshes dark spots and skin discolorations caused by acne, aging, sun damage, and pregnancy. This special formula is fortified with Carrot Oil and Vitamins A and E to help restore and maintain skin's essentialmoisture balance leaving your skin feeling beautifully softand smooth. This light, fast absorbing lotion safely fades and evens complexion for younger and healthier looking skin.
- INGREDIENTS AND APPEARANCE
TOTAL WHITE BRIGHTENING
hydroquinone, ethylhexyl methoxycinnamate lotion
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53218-001 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 14.19 mg in 473 mL Hydroquinone (Hydroquinone) Hydroquinone 9.46 mg in 473 mL Inactive Ingredients Ingredient Name Strength Water Coco-caprylate/caprate Stearic Acid Polyethylene Glycol 400 Cetyl Alcohol Stearyl Stearate Glyceryl Monostearate Propylene Glycol Kojic Acid Carrot Seed Oil Pentetic Acid Corn Oil Xanthan Gum .alpha.-tocopherol Acetate Vitamin A Palmitate .beta.-carotene Sodium Sulfite Sodium Metabisulfite Edetate Sodium Methylparaben Propylparaben Dmdm Hydantoin Polyethylene Glycol 4500 Sugarcane Orange Lemon Bilberry Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53218-001-01 473 mL in 1 BOTTLE, PLASTIC 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)