FDA.reportPublic FDA data

SUN ULTIMATE FACE CREAM SPF 30

Manufacturer
Naos USA, Inc. | MF PRODUCTIONS SAUMUR
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:19:42

Label at a glance#

ProductSUN ULTIMATE FACE SPF 30
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE
Label structure8 sections

Dosage and administration

Adult 18 years old and older: Apply liberally and evenly 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 value of 15 or higher and other sun protection measures i...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9%

Octisalate 4.5%

Avobenzone 2.7

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use 

OTC - DO NOT USE SECTION

on broken skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult 18 years old and older:

  • Apply liberally and evenly 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.; and 
  • Wear long-sleeve shirts, pants hats and sunglasses.
  • Children under 6 months of age: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Keep the product between 15-30°C (59-86°F)
  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Ethylhexyl Methoxycrylene, Butyloctyl Salicylate, Glycerin, Tribehenin Peg-20 Esters, Pentylene Glycol, Coco-Caprylate/Caprate, Dimethicone, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-Cresol, Cetearyl Alcohol Vp/Eicosene Copolymer, C20-22 Alkyl Phosphate, Creatine, Glyceryl Stearate, Glycyrrhetinic Acid, Mannitol, Peg-100 Stearate, C20-22 Alcohols Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Polysilicone-11, Caprylyl Glycol, 1,2-Hexanediol, Sodium Citrate, Hydrolyzed Soy Protein, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Hydrolyzed Wheat Protein, Propylene Glycol, Sodium Hydroxide, Butylene Glycol, Polysorbate 60, Sorbitan Isostearate, Alcohol, Phenoxyethanol, Tris(Tetramethylhydroxypiperidinol) Citrate, Carnosin, Artemia Extract, Disodium Adenosine Triphosphate, Laminaria Digitata Extract, Tocopherol

Questions?

OTC - QUESTIONS SECTION

Call 1-877-443-3762

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14324-02014324-020-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
TRIBEHENIN PEG-20 ESTERS84K9EH29Y9IACT
PENTYLENE GLYCOL50C1307PZGIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
CREATINEMU72812GK0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ENOXOLONEP540XA09DRIACT
MANNITOL3OWL53L36AIACT
PEG-100 STEARATEYD01N1999RIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SODIUM CITRATE1Q73Q2JULRIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW)J2S07SB0YLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE7NW772I64YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARNOSINE8HO6PVN24WIACT
ADENOSINE TRIPHOSPHATE DISODIUM5L51B4DR1GIACT
LAMINARIA DIGITATA15E7C67EE8IACT
TOCOPHEROLR0ZB2556P8IACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b41a486-6e3a-a1a7-e063-6294a90ace2110345ec6-b490-495c-9b56-c94383e8a2122023-11-28WarningsExact identifier
spl id: 0b41a486-6e3a-a1a7-e063-6294a90ace21
spl set id: 10345ec6-b490-495c-9b56-c94383e8a212

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.