Active Ingredient(S)
Titanium Dioxide 2.35%, Zinc Oxide 13.5%
Reflecting Mineral Sunscreen Lotion
FDA Label NDC 85767-610
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Helande, Llc for the product Reflecting Mineral Sunscreen (NDC 85767-610). 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 active ingredient(s), purpose:, warnings, use(s):, warnings:, directions:, inactive ingredients:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Sunscreen.
Warnings
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Use(S):
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings:
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
- Shake well before use.
- Apply liberally and evenly 15 minutes before sun exposure.
- Use a water-resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Sun Protection Measures.
- Limit time in the sun especially from 10a.m.-2p.m.
- Wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months: Ask a doctor.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including:
Inactive Ingredients:
Aqua (Water), C12-15 Alkyl Benzoate, Glycerin, Galactoarabinan, Ethylhexyl Palmitate, Argania Spinosa Kernel Oil, Tocopheryl Acetate (D-alpha), Caprylic/Capric Triglyceride, Polysorbate 60, Lithothamnion Calcareum Powder, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Phenoxyethanol, Isostearic Acid, Coco-Glucoside, Xanthan Gum, Mannitol, Benzyl Alcohol, 1,2-Hexanediol, Caprylyl Glycol, Polyhydroxystearic Acid, Bisabolol (L-alpha), Alumina, Stearic Acid, Sodium Gluconate, Diatomaceous Earth, Caprylhydroxamic Acid, Ethylhexylglycerin, Zinc Sulfate, Tropolone, Maltodextrin, Camellia Sinensis (Green Tea) Leaf Extract, Camellia Sinensis (White Tea) Leaf Extract, Dimethylmethoxy Chromanol, Pollia Condensata Fruit Extract, Coenochloris Signiensis Extract, Lecithin, Ergothioneine
Other Information:
- Protect this product from excessive heat and direct sun.
Package Label.Principal Display Panel
Pdp (85767 610 01label)
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