FDA Label for Odlumivie Tinted Mineral Sunscreen
View Indications, Usage & Precautions
Odlumivie Tinted Mineral Sunscreen Product Label
The following document was submitted to the FDA by the labeler of this product Guangzhou Meijiao Medical Biotechnology Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Zinc Oxide ..... 6.0% ..... Sunscreen
Titanium Dioxide ..... 4.5% ..... Sunscreen
Inactive Ingredient
INACTIVE INGREDIENTS:
Water
Ethylhexyl Palmitate
Cetyl Ethylhexanoate
Tinosorb S (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine)
Butyloctyl Salicylate
Pentaerythrityl Tetraethylhexanoate
Potassium Cetyl Phosphate
Cetearyl Alcohol
Hemisqualane
Silica
Glyceryl Stearate
Sodium PCA
Panthenol
Niacinamide
Ascorbyl Glucoside
Sodium Hyaluronate
Acetylated Sodium Hyaluronate
Cross-linked Sodium Hyaluronate
Hydrolyzed Sodium Hyaluronate
Polypodium Leucotomos Extract
Green Tea Extract
Fullerene
Collagen Peptide
Pro-Xylane
Tri(Cetearyl-4) Phosphate
Aluminum Hydroxide
Stearic Acid
Tocopheryl Acetate
Natural Bisabolol
Otc - Purpose
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), it helps minimize signs of UV-induced skin aging.
Warnings
WARNINGS:
For external use only. Avoid contact with eyes. Discontinue use if irritation occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
DO NOT USE:
Do not use on damaged or broken skin.
Do not use if you are allergic to any of the ingredients in this product.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
STOP USE AND ASK A DOCTOR IF:
Irritation or rash develops.
Indications & Usage
DIRECTIONS:
Apply to clean, dry skin 15 minutes before sun exposure. Reapply every 2 hours or after swimming, sweating, or towel drying.
Otc - When Using
WHEN USING THIS PRODUCT:
Keep out of eyes. Rinse with water to remove.
Dosage & Administration
Apply to clean, dry skin 15 minutes before sun exposure. Reapply every 2 hours or after swimming, sweating, or towel drying. use 1-2ml on targeting areas
Package Label.Principal Display Panel
DRUG FACTS
Active Ingredients Purpose
Zinc Oxide 6.0% Sunscreen
Titanium Dioxide 4.5% Sunscreen
USES:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), it helps minimize signs of UV-induced skin aging.
WARNINGS:
For external use only. Avoid contact with eyes. Discontinue use if irritation occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS:
Apply to clean, dry skin 15 minutes before sun exposure. Reapply every 2 hours or after swimming, sweating, or towel drying.
OTHER INFORMATION:
Store at 15–40°C (59–104°F). Keep container tightly closed and avoid extreme heat or direct sun exposure.
INACTIVE INGREDIENTS:
Water, Ethylhexyl Palmitate, Cetyl Ethylhexanoate, Tinosorb S (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine), Butyloctyl Salicylate, Pentaerythrityl Tetraethylhexanoate, Potassium Cetyl Phosphate, Cetearyl Alcohol, Hemisqualane, Silica, Glyceryl Stearate, Sodium PCA, Panthenol, Niacinamide, Ascorbyl Glucoside, Sodium Hyaluronate, Acetylated Sodium Hyaluronate, Cross-linked Sodium Hyaluronate, Hydrolyzed Sodium Hyaluronate, Polypodium Leucotomos Extract, Green Tea Extract, Fullerene, Collagen Peptide, Pro-Xylane, Tri(Cetearyl-4) Phosphate, Aluminum Hydroxide, Stearic Acid, Tocopheryl Acetate, Natural Bisabolol
* Please review the disclaimer below.
