SUPER SOLAIRE SUN SENSITIVE AREAS TINTED SPF 30- titanium dioxide, zinc oxide stick

SUPER SOLAIRE sun sensitive areas tinted by

Drug Labeling and Warnings

SUPER SOLAIRE sun sensitive areas tinted by is a Otc medication manufactured, distributed, or labeled by C.F.E.B. Sisley. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium dioxide 9.5%
Zinc oxide 18.75%

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 15 minutes before sun exposure.
• Reapply:
• After 80 minutes of swimming or sweating.
• Immediately after towel drying.
• At least every 2 hours.
• Children under 6 months of age: ask a doctor.
• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 am to 2 pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
  

Other information

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

Inactive ingredients

dicaprylyl carbonate, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, soybean glycerides, butyrospermum parkii (shea butter), euphorbia cerifera (candelilla) wax, hydroxystearic/linolenic/oleic polyglycerides, polyethylene, butyrospermum parkii (shea) butter unsapoiliables, camellia oleifera seed oil, glyceryl isostearate, glyceryl behenate, iron oxides (CI 77492), mangifera indica (mango) seed butter, tocopheryl acetate, squalane, polyhydroxystearic acid, trimethoxycaprylylsilane, talc, ammonium glycyrrhizate, tocopherol, ascorbyl palmitate, iron oxides (CI 77491), iron oxides (CI 77499), titanium dioxide (CI 77891).

sisley PARIS

Tinted sun control stick SPF 30, for sun-sensitive areas (nose, cheekbones, eye contour).  Easy to apply, soft non-oily texture, optimum comfort.  Water-resistant. 
Sisley USA  7 Renaissance Square, 3rd Floor, White Plains, NY 10601  Distributed by:  C.F.E.B. sisley  16, avenue George V  75008 PARIS - FRANCE   www.sisley-usa.com  Made in France

PRINCIPAL DISPLAY PANEL

SUPER STICK SOLAIRE  sun-sensitive areas  tinted  Sunscreen Broad Spectrum SPF 30   Water Resistant (80 minutes)   sisley PARIS  NET WT. 0.38 OZ.  11g

Product Labels

INGREDIENTS AND APPEARANCE

SUPER SOLAIRE SUN SENSITIVE AREAS TINTED  SPF 30
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66097-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	95 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	187.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CAMELLIA OIL (UNII: T1PE06G0VE)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALANE (UNII: GW89575KF9)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
TALC (UNII: 7SEV7J4R1U)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66097-006-11	1 in 1 BOX	01/23/2013	12/31/2021
1		11 g in 1 CONTAINER; 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	01/23/2013	12/31/2021

Labeler - C.F.E.B. Sisley (277517827)