SIROT DAYTIME HAND PERFECTION TRANSFORMATIVE GLASS TECHNOLOGY MOISTURIZING 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 Daytime Hand Perfection Cream 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 ( SeeDirections), 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 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • ​Sun Protection Measures​: Spending tim 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), 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/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, fragrance (*100% natural fragrance), phenoxyethanol

Package Labeling:

LABEL

sieml2ml

Label2

SIROT DAYTIME HAND PERFECTION TRANSFORMATIVE GLASS TECHNOLOGY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 20 
octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70803-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM SILICATE (UNII: IJF18F77L3)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
NIACINAMIDE (UNII: 25X51I8RD4)  
MICA (UNII: V8A1AW0880)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MACADAMIA OIL (UNII: 515610SU8C)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TEA LEAF (UNII: GH42T47V24)  
CANANGA OIL (UNII: 8YOY78GNNX)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
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)  
CERAMIDE NG (UNII: C04977SRJ5)  
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:70803-420-00100 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package07/05/201612/29/2017
2NDC:70803-420-011 in 1 PACKAGE07/05/201612/29/2017
22 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:70803-420-301 in 1 BOX07/05/201612/29/2017
330 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/05/201612/29/2017
Labeler - SIBORG (102875148)

Revised: 1/2021
Document Id: 9ab40f3c-d71b-e12a-e053-2995a90a2b3e
Set id: 668aafe1-8ca5-4a61-9c7f-346a94a22584
Version: 8
Effective Time: 20210126
 
SIBORG