SOLEIL SUN CREME SOLAIRE VISAGE ET CORPS SUNSCREEN FACE AND BODY SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octinoxate, octisalate cream

SOLEIL SUN Creme Solaire Visage et corps Sunscreen Face and Body Sunscreen Broad Spectrum SPF30 by

Drug Labeling and Warnings

SOLEIL SUN Creme Solaire Visage et corps Sunscreen Face and Body Sunscreen Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Codif International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 2.7%
Homosalate 7%
Octinoxate 6.7%
Octisalate 4.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn.
• if used as directed with other sun protection measures (see Directions), decreases the risk of sun cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

on damaged skin 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 two hours
• use a water resistant sunscreen if swimming or sweating
• Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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. - 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

Inactive Ingredients

Water, butyloctyl salicylate, ethylhexyl methoxycrylene, dicaprylyl carbonate, butylene glycol cocoate, glycerin, polyglyceryl-6 distearate, styrene/acrylates copolymer, jojoba esters, dimethicone, phenoxyethanol, potassium cetyl phosphate, fragrance, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyglyceryl-3 beeswax, xanthan gum, cetyl alcohol, chlorphenesin, peg-8 laurate, dimethiconol, 1,2-hexanediol, caprylyl glycol, disodium edta, polysorbate 60, sorbitan isostearate, sea salt, bht, tocopherol.

Questions or comments?

Call toll free 1-800-227-8051

Package Labeling: (

66846-015-01) 

Package Labeling: (

66846-015-04)

INGREDIENTS AND APPEARANCE

SOLEIL SUN CREME SOLAIRE VISAGE ET CORPS SUNSCREEN FACE AND BODY SUNSCREEN BROAD SPECTRUM SPF30 
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66846-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORPHENESIN (UNII: I670DAL4SZ)
PEG-8 LAURATE (UNII: 762O8IWA10)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SEA SALT (UNII: 87GE52P74G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66846-015-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/15/2019
2	NDC: 66846-015-04	125 mL in 1 TUBE; Type 0: Not a Combination Product	03/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2019

Labeler - Codif International (396156010)