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  5. Label Information: Sekkisei Treatment Bb 01

FDA Label for Sekkisei Treatment Bb 01

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. OTC - STOP USE
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. OTHER INFORMATION
    12. PRINCIPAL DISPLAY PANEL - 00 CARTON LABEL
    13. PRINCIPAL DISPLAY PANEL - 00 TUBE LABEL
    14. PRINCIPAL DISPLAY PANEL - 01 CARTON LABEL
    15. PRINCIPAL DISPLAY PANEL - 01 TUBE LABEL

Sekkisei Treatment Bb 01 Product Label

The following document was submitted to the FDA by the labeler of this product Kose America, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



OCTINOXATE 7.4%

ZINC OXIDE 5.9%


Purpose



Sunscreen

Sunscreen


Use



helps prevent sunburn


Warnings



For external use only.


Otc - Do Not Use



Do not use on damaged or broken skin.


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.


Keep Out Of Reach Of Children.



If product is swallowed, get medical help or contact a 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
  • 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:
  • 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: Ask a doctor

Inactive Ingredients



WATER/AQUA/EAU · CYCLOMETHICONE · METHYL TRIMETHICONE · ALCOHOL · GLYCERIN · ETHYLHEXYL PALMITATE · DIISOSTEARYL MALATE · PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE · DISTEARDIMONIUM HECTORITE · TRIETHYLHEXANOIN · ALPINIA SPECIOSA LEAF EXTRACT · ANGELICA ACUTILOBA ROOT EXTRACT · CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT · COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT · MELOTHRIA HETEROPHYLLA ROOT EXTRACT · TOCOPHEROL · ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER · ALUMINUM HYDROXIDE · BHT · BUTYLENE GLYCOL · DIMETHICONE · DISODIUM STEAROYL GLUTAMATE · HYDROGEN DIMETHICONE · LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE · METHYL METHACRYLATE CROSSPOLYMER · PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE · PHYTOSTERYL/ISOSTERYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE · POLYISOPRENE · POLYPROPYLENE · SILICA · SODIUM CHLORIDE · STEARALKONIUM HECTORITE · TALC · TRIETHOXYCAPRYLYLSILANE · METHYLPARABEN · FRAGRANCE (PARFUM) · MAY CONTAIN (+/-): IRON OXIDES (CI 77491) · IRON OXIDES (CI 77492) · IRON OXIDES (CI 77499) · TITANIUM DIOXIDE (CI77891)


Other Information



Protect this product from excessive heat and direct sun


Principal Display Panel - 00 Carton Label



BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

e 26 mL NET WT. 1 OZ.


Principal Display Panel - 00 Tube Label



BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE


Principal Display Panel - 01 Carton Label



BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE

e 26 mL NET WT. 1 OZ.


Principal Display Panel - 01 Tube Label



BB

SEKKISEI

TRETMENT BB CREAM

Broad Spectrum SPF 37
Sunscreen

KOSE


* Please review the disclaimer below.