SIROT COMPLETE HAND CARE COLLECTION TRANSFORMATIVE GLASS TECHNOLOGY HYDRATE RESTORE PROTECT- octinoxate, octocrylene, titanium dioxide, zinc oxide kit

Sirot complete Hand Care Collection Transformative Glass Technology Hydrate Restore Protect by

Drug Labeling and Warnings

Sirot complete Hand Care Collection Transformative Glass Technology Hydrate Restore Protect by is a Otc medication manufactured, distributed, or labeled by Siborg LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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), 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:

INGREDIENTS AND APPEARANCE

SIROT COMPLETE HAND CARE COLLECTION TRANSFORMATIVE GLASS TECHNOLOGY HYDRATE RESTORE PROTECT 
octinoxate, octocrylene, titanium dioxide, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70803-550

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70803-550-00	1 in 1 KIT	04/12/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	100 mL

Part 1 of 1

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.2 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
TEA LEAF (UNII: GH42T47V24)
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)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70803-420-00	100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/12/2017

Labeler - Siborg LLC (102875148)