Reflecting Mineral Sunscreen ZINC OXIDE TITANIUM DIOXIDE HELANDE, LLC FDA Approved 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.
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Substance Titanium Dioxide
Route
TOPICAL
Applications
M020
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient(s) Titanium Dioxide 2.35% Zinc Oxide 13.5%
Inactive Ingredients
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
Strengths
13.5 %
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
15FIX9V2JP SOI2LOH54Z
Packaging

PDP

Package Descriptions
  • PDP

Overview

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.

Indications & Usage

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.

Dosage & Administration

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. 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: 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.

Warnings & Precautions
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.
Purpose

Purpose: Sunscreen.

Keep Out of Reach of Children

WARNINGS Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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