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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Avobenzone 2.7% Homosalate 7% Octinoxate 6.7% Octisalate 4.5%, Sunscreen
Available from:
Codif International
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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.
Authorization status:
OTC monograph not final
Authorization number:
66846-015-01, 66846-015-04

SOLEIL SUN CREME SOLAIRE VISAGE ET CORPS SUNSCREEN FACE AND BODY

SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octinoxate,

octisalate cream

Codif International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SOLUTION SOLEIL SUN SOLUTION Creme Solaire Visage et corps Sunscreen Face and Body

Sunscreen Broad Spectrum SPF30

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

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)

SOLEIL SUN CREME SOLAIRE VISAGE ET CORPS SUNSCREEN FACE AND

BODY SUNSCREEN BROAD SPECTRUM SPF30

avobenzone, homosalate, octinoxate, octisalate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 8 46 -0 15

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

27 mg in 1 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

70 mg in 1 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 7 mg in 1 mL

Codif International

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

45 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

XANTHAN GUM (UNII: TTV12P4NEE)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

PEG-8 LAURATE (UNII: 76 2O8 IWA10 )

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

SO RBITAN ISO STEARATE (UNII: 0 1S2G2C1E4)

SEA SALT (UNII: 8 7GE52P74G)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

ETHYLHEXYL METHO XYCRYLENE (UNII: S3KFG6 Q5X8 )

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT)

HYDRO XYETHYL ACRYLATE/SO DIUM ACRYLO YLDIMETHYL TAURATE CO PO LYMER ( 10 0 0 0 0 MPA.S AT

1.5%) (UNII: 8 6 FQE9 6 TZ4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 8 46 -0 15-0 1

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/15/20 19

2

NDC:6 6 8 46 -0 15-0 4

125 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/15/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/15/20 19

Labeler -

Codif International (396156010)

Revised: 2/2019

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