SUPER CREME SOLAIRE CORPS BODY SUN CARE SPF 15- avobenzone, octinoxate, octisalate, oxybenzone cream

SUPER CREME SOLAIRE CORPS Body sun care by

Drug Labeling and Warnings

SUPER CREME SOLAIRE CORPS Body sun care 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

Avobenzone 3 %
Octinoxate 5 %
Octisalate 5 %
Oxybenzone 4 %

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 at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• 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 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 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

water, dipropylene glycol dibenzoate, butylene glycol, glycerin, butyrospermum parkii (shea butter), helianthus annuus (sunflower) seed oil, isodecyl neopentanoate, dimethicone, physalis alkekengi calyx extract, cetearyl alcohol, lauryl glucoside, polyglyceryl-2 dipolyhydroxystearate, phenoxyethanol, potassium cetyl phosphate, polyacrylamide, carbomer, elaeis guineensis (palm) oil, c13-14 isoparaffin, tocopheryl acetate, lavandula angustifolia (lavender) oil, sodium methyl paraben, allantoin, ceteareth-20, tetrasodium edta, pelargonium graveolens oil, sorbic acid, pentylene glycol, laureth-7, sodium hydroxide, citric acid, cetyl alcohol, bht, potassium sorbate, linalool, limonene, geraniol, citronellol, citral

PRINCIPAL DISPLAY PANEL

SUPER CREME SOLAIRE CORPS  Body sun care   Sunscreen Cream  Broad Spectrum SPF 15  sisley PARIS  6.7 FL.OZ.  200 ml   Sisley USA  7 Renaissance Square, 3rd Floor, White Plains, NY 10601

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUPER CREME SOLAIRE CORPS BODY SUN CARE   SPF 15
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66097-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
SHEANUT OIL (UNII: O88E196QRF)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHYSALIS ALKEKENGI CALYX (UNII: AL7F9NO9HR)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PALM OIL (UNII: 5QUO05548Z)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
ALLANTOIN (UNII: 344S277G0Z)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
EDETATE SODIUM (UNII: MP1J8420LU)
XANTHAN GUM (UNII: TTV12P4NEE)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
SORBIC ACID (UNII: X045WJ989B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66097-004-00	1 in 1 BOX	01/21/2013
1		200 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	01/21/2013

Labeler - C.F.E.B. Sisley (262279246)