SIROT The Complete Beauty Experience Kit

SIROT The Complete Beauty Experience Transformative Glass Technology The First Steps to Younger Looking Skin by

Drug Labeling and Warnings

SIROT The Complete Beauty Experience Transformative Glass Technology The First Steps to Younger Looking Skin by is a Otc medication manufactured, distributed, or labeled by SIBORG, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SIROT THE COMPLETE BEAUTY EXPERIENCE TRANSFORMATIVE GLASS TECHNOLOGY THE FIRST STEPS TO YOUNGER LOOKING SKIN- octocrylene, zinc oxide, titanium dioxide, octinoxate 
SIBORG, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SIROT The Complete Beauty Experience Kit

SIROT Daytime Hand Perfection Transformative Glass Technology Moisturizing Sunscreen Broad Spectrum SPF 20

Drug Facts

Active ingredients

Octinoxate 6.0%

Octocrylene 2.5%

Titanium dioxide 0.22%

Zinc oxide 2.9%

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.

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.

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • Reapply at least every 2hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures: Spending time in the sun increasesyour risk of skin cancer and early skin aging. Todecrease thisrisk, regularly use a sunscreen with a broad spectrum SPF valueof 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • 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 (aqua), glycerin, cetearyl alcohol, octyldodecanol, isononyl isononanoate, butylene glycol, dimethicone, aluminum starch octenylsuccinate, cetearyl olivate, cetyl alcohol, sorbitan olivate, panthenol, sodium silicate, dioleyl tocopheryl methylsilanol, macadamia ternifolia seed oil, shea (butyrospermum parkii) butter, aloe (aloe barbadensis) leaf extract, sodium ascorbyl phosphate, tea (camellia sinensis) leaf extract, ylang ylang (cananga odorata) flower oil, tribehenin, ceramide ng, peg-10 phytosterol, niacinamide, oleyl alcohol, sodium hyaluronate crosspolymer, hydrogenated ethylhexyl olivate, xanthan gum, polysorbate 60, caprylyl glycol, mica, citric acid, acrylates/c 10-30 alkyl acrylate crosspolymer, hexylene glycol, triethoxycaprylylsilane, tocopheryl acetate, disodium edta, hydrogenated olive oil unsaponifiables, c12-15 alkyl benzoate, pentylene glycol, hydrogenated lecithin, ethylhexylglycerin, palmitoyl hexapeptide-12, retinyl palmitate, sodium methyl stearoyl taurate, fragrance (*100% natural fragrance), phenoxyethanol

SIROT Essential Day Transformative Glass Technology Anti-Aging Sunscreen Broad Spectrum SPF 20

Drug Facts

Active ingredients

Octocrylene 2.5 %

Zinc Oxide 3.8%

Titanium Dioxide 0.7%

Octinoxate 6.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

  • keep out of eyes
  • rinse with water to remove

Stop use and ask a doctor if

  • rash or irritation develops and lasts

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply evenly before sun exposure
  • reapply as needed
  • children under 6 months of age: ask a doctor

Other information

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.

Inactive ingredients:

Aqua (Water), Glycerin, Cetearyl Alcohol, Octyldodecanol, Isononyl Isononanoate, Butylene Glycol, Dimethicone, Aluminum Starch Octenylsuccinate, Cetearyl Olivate, Cetyl Alcohol, Sorbitan Olivate, Panthenol, Sodium Silicate, Dioleyl Tocopheryl Methylsilanol, Macadamia Ternifolia Seed Oil, Butyrospermum Parkii (Shea Butter), Aloe Barbadensis Leaf Extract, Sodium Ascorbyl Phosphate, Camellia Sinensis Leaf Extract, Cananga Odorata (Ylang Ylang) Flower Oil, Tribehenin, Ceramide Ng, Peg-10 Phytosterol, Niacinamide, Oleyl Alcohol, Sodium
Hyaluronate Crosspolymer,hydrogenated Ethylhexyl Olivate, Xanthan Gum, Polysorbate 60, Caprylyl Glycol, Mica, Citric Acid, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Hexylene Glycol, Triethoxycaprylylsilane, Tocopheryl Acetate, Disodium Edta, Hydrogenated Olive Oil Unsaponifiables, C12-15 Alkyl Benzoate, Pentylene Glycol, Hydrogenated Lecithin, Ethylhexylglycerin, Palmitoyl Hexapeptide-12, Retinyl Palmitate, Sodium Methyl Stearoyl Taurate, Parfum (Fragrance), Phenoxyethanol

Package Labeling

CBPKit1CBPKit2EDCEDC2DHPC30

SIROT THE COMPLETE BEAUTY EXPERIENCE TRANSFORMATIVE GLASS TECHNOLOGY THE FIRST STEPS TO YOUNGER LOOKING SKIN 
octocrylene, zinc oxide, titanium dioxide, octinoxate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70803-400
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70803-400-001 in 1 KIT06/30/201612/29/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 50 mL
Part 21 TUBE 30 mL
Part 1 of 2
SIROT ESSENTIAL DAY TRANSFORMATIVE GLASS TECHNOLOGY ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF 20 
octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC: 70803-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
PANTHENOL (UNII: WV9CM0O67Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM SILICATE (UNII: IJF18F77L3)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CANANGA OIL (UNII: 8YOY78GNNX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SHEA BUTTER (UNII: K49155WL9Y)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)  
MACADAMIA OIL (UNII: 515610SU8C)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70803-410-501 in 1 BOX
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/30/2016
Part 2 of 2
SIROT DAYTIME HAND PERFECTION TRANSFORMATIVE GLASS TECHNOLOGY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 20 
octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC: 70803-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION29 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM SILICATE (UNII: IJF18F77L3)  
MACADAMIA OIL (UNII: 515610SU8C)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CANANGA OIL (UNII: 8YOY78GNNX)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CERAMIDE NG (UNII: C04977SRJ5)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MICA (UNII: V8A1AW0880)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70803-420-301 in 1 BOX
130 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/30/201612/29/2017
Labeler - SIBORG, LLC (102875148)

Revised: 12/2019
 
SIBORG, LLC