Samhealthyskin B.b. Sunscreen Broad Spectrum Spf 40
FDA Label NDC 57650-159
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Samhealthyskin.com Llc for the product Samhealthyskin B.b. Sunscreen Broad Spectrum Spf 40 (NDC 57650-159). 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 samhealthyskin b.b. sunscreen cream broad spectrum spf 40, active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Titanium Dioxide 10%
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
When using this product
- keep out of eyes. Rinse with water to remove.
- rash occurs
Stop use and ask a doctor if
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
For sunscreen use
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Limit time in the sun, especially from 10 a.m.– 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
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 value of 15 or higher and other sun protection measures including:
Children under 6 months of age: Ask a doctor
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
WATER, MINERAL OIL, CYCLOMETHICONE, PROPYLENE GLYCOL, DIMETHICONE/PEG-10/15 CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, TALC, IRON OXIDES, HYALURONIC ACID, BEESWAX, MICROCRYSTALLINE WAX, SHEA (BUTYROSPERMUM PARKII) BUTTER, TRIBEHENIN, SORBITAN SESQUIOLEATE, SOLUBLE COLLAGEN, TOCOPHERYL ACETATE, ALLANTOIN, TEA (CAMELLIA SINENSIS) LEAF EXTRACT, WHITE MULBERRY (MORUS ALBA) BARK EXTRACT, LICORICE (GLYCYRRHIZA GLABRA) ROOT EXTRACT, DIPOTASSIUM GLYCYRRHIZATE, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, DISODIUM EDTA, RED GINSENG (PANAX GINSENG)EXTRACT, SODIUM CHLORIDE, FRAGRANCE
Samhealthyskin B.B. Sunscreen Cream Broad Spectrum Spf 40 1.69Oz/50Ml (57650-159-79)
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