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NDC 66846-0015-04 SOLEIL SUN Creme Solaire Visage et corps Sunscreen Face and Body Sunscreen Broad Spectrum SPF30 27; 70; 67; 45 mg/mL; mg/mL; mg/mL; mg/mL Details

SOLEIL SUN Creme Solaire Visage et corps Sunscreen Face and Body Sunscreen Broad Spectrum SPF30 27; 70; 67; 45 mg/mL; mg/mL; mg/mL; mg/mL

SOLEIL SUN Creme Solaire Visage et corps Sunscreen Face and Body Sunscreen Broad Spectrum SPF30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Codif International. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE.

Product Information

NDC	66846-0015
Product ID	66846-015_d3092168-216e-2d9d-e053-2995a90ae024
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SOLEIL SUN Creme Solaire Visage et corps Sunscreen Face and Body Sunscreen Broad Spectrum SPF30
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	27; 70; 67; 45
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Labeler Name	Codif International
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	n/a

Package

Package Images

NDC 66846-0015-04 (66846001504)

Pricing Information	N/A
NDC Package Code	66846-015-04
Billing NDC	66846001504
Package	125 mL in 1 TUBE (66846-015-04)
Marketing Start Date	2019-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 88d388be-a0d8-4df5-a2ed-322c4787a8a5 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66846-015-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/15/2019	06/30/2023
2	NDC:66846-015-04	125 mL in 1 TUBE; Type 0: Not a Combination Product	03/15/2019	06/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/15/2019	06/30/2023

Labeler - Codif International (396156010)

Revised: 12/2021

Document Id: d3092168-216e-2d9d-e053-2995a90ae024

Set id: 88d388be-a0d8-4df5-a2ed-322c4787a8a5

Version: 5

Effective Time: 20211213