Active Ingredients
Zinc Oxide 12.4%
Traceless Mineral Broad Spectrum Spf Sunscreen And Primer Cream
FDA Label NDC 83282-851
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beauty Pie U.s.a. Inc. for the product Traceless Mineral Broad Spectrum Spf Sunscreen And Primer (NDC 83282-851). 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 ingredients, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
Uses
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. Stop use and ask doctor if rash occurs. When using, this product should be kept away from eye area. Rinse with water to remove.
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.
Directions
Apply liberally 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 risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun especially from 10:00 a.m. - 2:00 p.m. Wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.
Other Information
PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN. MAY STAIN SOME FABRICS
Inactive Ingredients
Water,C12-15 Alkyl Benzoate,Dimethicone,Argania Spinosa Kernel Oil,Tocopheryl Acetate,Cetearyl Alcohol,Propanediol,
Niacinamide,Polyhydroxystearic acid,Coco-Glucoside,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer ,Glyceryl Stearate ,PEG-100 Stearate ,Silica ,Isohexadecane ,Pongamia Pinnata Seed Extract ,Xanthan Gum ,Bisabolol ,Citric Acid ,Hydroxyacetophenone ,Triethoxycaprylylsilane,Polysorbate 80,Polysilicone-11 ,Ethylhexylglycerin ,Trisodium Ethylenediamine Disuccinate ,Sodium Hydroxide ,Phenoxyethanol ,Yellow 5,Red 40
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