SIROT ESSENTIAL DAY CREAM TRANSFORMATIVE GLASS TECHNOLOGY (TM) ANTI-AGING SUNSCREEN BROAD SPECTRUM, SPF 20

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

Drug Labeling and Warnings

SIROT Essential Day Transformative Glass Technology Anti-Aging Sunscreen Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by SIBORG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SIROT ESSENTIAL DAY TRANSFORMATIVE GLASS TECHNOLOGY ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF 20- octinoxate, octocrylene, titanium dioxide, zinc oxide cream 
SIBORG

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 ESSENTIAL DAY CREAM TRANSFORMATIVE GLASS TECHNOLOGY (TM) ANTI-AGING SUNSCREEN BROAD SPECTRUM, SPF 20

Drug Facts

​Active ingredients

Octinoxate 6.0%
Octocrylene 2.5%
Titanium dioxide 0.7%
Zinc oxide 3.8%

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

​Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • Reapply atleast 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 of age:  Ask a doctor

​Other information

  • Protect the product in this container from excessive heat and direct sun.

​Inactive ingredients

water (aqua), cetearyl alcohol, glycerin, cyclopentasiloxane, butylene glycol, dicaprylyl ether, c12-15 alkyl ethylhexanoate, cetearyl olivate, mica, sorbitan olivate, panthenol, dimethicone, sodium silicate, dioleyl tocopheryl methylsilanol, sodium hyaluronate crosspolymer, hydrogenated ethylhexyl olivate, polysorbate 60, acrylates copolymer, cetyl alcohol, caprylyl glycol, citric acid, xanthan gum, calendula officinalis flower extract, triethoxycaprylylsilane, acrylates/c10-30 alkyl acrylate crosspolymer, hexylene glycol, tocopheryl acetate, disodium edta, hydrogenated olive oil unsaponifiables, hydrolyzed soybean fiber, aloe (aloe barbadensis) leaf extract, vp/polycarbamyl polyglycol ester, hydrolyzed sesame
protein pg-propyl methylsilanediol, ylang ylang (cananga odorata) flower oil, pentylene glycol, carbomer, polysorbate 20, shea (butyrospermum
parkii) butter, niacinamide, allantoin, sodium ascorbyl phosphate, oleyl alcohol, hydrogenated lecithin, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, soluble collagen, retinyl palmitate, sodium methyl stearoyl taurate, macadamia ternifolia seed oil, fragrance (*100% natural fragrance), phenoxyethanol,ethylhexylglycerin

​Package Labeling:

image description

image description

SIROT ESSENTIAL DAY TRANSFORMATIVE GLASS TECHNOLOGY ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF 20 
octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem 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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
MICA (UNII: V8A1AW0880)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
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)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CANANGA OIL (UNII: 8YOY78GNNX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
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)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
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 BOX07/05/201606/06/2018
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 finalpart35207/05/201606/06/2018
Labeler - SIBORG (102875148)

Revised: 12/2019
 
SIBORG