Otc - Active Ingredient
Zinc Oxide ..... 6.0% ..... Sunscreen
Titanium Dioxide ..... 4.5% ..... Sunscreen
Odlumivie Tinted Mineral Sunscreen Cream
FDA Label NDC 87036-036
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Meijiao Medical Biotechnology Co., Ltd. for the product Odlumivie Tinted Mineral Sunscreen (NDC 87036-036). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - stop use, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Design (Tinted Sunscreen)
* Please review the disclaimer below.
