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Hera Silkystay Foundation 23c2 Lotion
FDA Label NDC 43419-208
13 label sections · Submitted to the FDA by Amorepacific Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amorepacific Corporation for the product Hera Silkystay Foundation 23c2 (NDC 43419-208). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
TITANIUM DIOXIDE 1.62%
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
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
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.
Directions
◼ Apply liberally 15 minutes before sun exposure.
◼ Reapply at least every 2 hours.
◼ Use a water resistant sunscreen if swimming or sweating.
◼ Sun Protection Meausres. Spending time in the sun increase 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:
· limit time in the sun, especially from 10 a.m.- 2 p.m.
· wear long-sleeved shirts, pants, hats, and sunglasses.
◼ Children under 6 months of age: Ask a doctor.
Other Safety Information
◼ Protect the product in this container from excessive heat and direct sun.
◼ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
◼ May stain some fabrics.
Inactive Ingredient
WATER / AQUA / EAU, CYCLOPENTASILOXANE, TITANIUM DIOXIDE (CI 77891), TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, PEG/PPG-18/18 DIMETHICONE, CYCLOHEXASILOXANE, NYLON-12, PEG-10 DIMETHICONE, IRON OXIDES (CI 77492), POLYGLYCERYL-3 DIISOSTEARATE, TRIBEHENIN, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, POLYMETHYLSILSESQUIOXANE, IRON OXIDES (CI 77491), ALUMINUM HYDROXIDE, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE / PARFUM, ALUMINA, CAPRYLYL GLYCOL, IRON OXIDES (CI 77499), GLYCERYL CAPRYLATE, SILICA DIMETHICONE SILYLATE, XANTHAN GUM, DISODIUM EDTA, SIMETHICONE, PROPANEDIOL, SODIUM HYALURONATE, HYDROLYZED HYALURONIC ACID, SODIUM HYALURONATE CROSSPOLYMER, HYALURONIC ACID, ETHYLHEXYLGLYCERIN, SODIUM ACETYLATED HYALURONATE
Package Label.Principal Display Panel
HERA
SILKY STAY
FOUNDATION
23C2 COOL SAND
BROAD SPECTRUM SPF 20
SUNSCREEN
30 g Net Wt. 1.05 oz.
23c2 (23c2)
* Please review the disclaimer below.
