SUN LOGIC CREME SOLAIRE VISAGE ET CORPS SPF 30- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion

Sun Logic Creme Solaire Visage et corps SPF 30 by

Drug Labeling and Warnings

Sun Logic Creme Solaire Visage et corps SPF 30 by is a Otc medication manufactured, distributed, or labeled by Guinot. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2.85%

Homosalate 14.00%

Octinoxate 7.12%

Octisalate 4.75%

Octocrylene 9.50%

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 product is 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
• 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 of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear long-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months: Ask a doctor.

Other information

• Protect this product from excessive heat and direct sun
• Store below 30°C/86°F

Inactive ingredients

Water/Eau (Aqua), Diisopropyl Adipate, Ceteareth-20, Propanediol, Caprylyl Methicone, Arachidyl Alcohol, Pentylene Glycol, Behenyl Alcohol, Sclerotium Gum, Fragrance (Parfum), Propylene Glycol, Arachidyl Glucoside, Glyceryl Caprylate, Potassium Cetyl Phosphate, Tocopheryl Acetate, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Betaine, Limonene, Pectin, Melanin, Sodium Chloride, Polysorbate 60, Sorbitan Isostearate, DNA, Sucrose, Alpha-Isomethyl Ionone, Glyceryl Acrylate/Acrylic Acid Copolymer, Ethylhexylglycerin, Capryloyl Glycine, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Sodium Hyaluronate, Triticum Vulgare (Wheat) Germ Protein, Caprylyl Glycol, Xanthan Gum. 01

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN LOGIC CREME SOLAIRE VISAGE ET CORPS SPF 30 
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54181-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	140 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	71.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	95 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DOCOSANOL (UNII: 9G1OE216XY)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
GLYCERIN (UNII: PDC6A3C0OX)
BETAINE (UNII: 3SCV180C9W)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PECTIN (UNII: 89NA02M4RX)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SUCROSE (UNII: C151H8M554)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WHEAT (UNII: 4J2I0SN84Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54181-011-00	1 in 1 BOX	12/23/2017
1		50 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 Drug	M020	12/23/2017

Labeler - Guinot (763667185)

Establishment
Name	Address	ID/FEI	Business Operations
Guinot		763667185	manufacture(54181-011)