FDA.reportPublic FDA data

SOFIE PAVITT FACE SPF 30

Manufacturer
COSMAX USA., CORP | COSMAX USA, CORP
Effective date
2026-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:47:44

Label at a glance#

ProductSOFIE PAVITT FACE SPF 30
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE
Label structure9 sections

Indications and uses

Use Help 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

Dosage and administration

Directions ​ Apply liberally and evenly15 minutes before sun exposure. Children under 6 months of age:Ask a doctor. SunProtectionMeasures. Spending time inthe sun increases your risk of skin cancer and early skin aging.To decrease this risk,regularty use a sunscreen with abroad spectrum SPFvalue of 15 or highe rand other sun protection measures including: limit your time in the sun,especially from 10a.m.-2p.m. wea...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Avobenzone 3.00%
Homosalate 7.00%
Octisalate 5.00%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

DOSAGE & ADMINISTRATION SECTION

Use

  • Help 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 SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

INDICATIONS & USAGE SECTION

Directions

​

  • Apply liberally and evenly15 minutes before sun exposure.
  • Children under 6 months of age:Ask a doctor.
  • SunProtectionMeasures. Spending time inthe sun increases your risk of skin cancer and early skin aging.To decrease this risk,regularty use a sunscreen with abroad spectrum SPFvalue of 15 or highe rand other sun protection measures including:
  • limit your time in the sun,especially from 10a.m.-2p.m.
  • wearlong-sleeved shirts,pants,hats,and sunglasses.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.

OTHER SAFETY INFORMATION

Other information

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, C12-15 Alkyl Benzoate,Glycerin, Butyloctyl Salicylate, Niacinamide, Propanediol, Pentylene Glycol Ectoin, Eugenia Caryophyllus (Clove) Bud Extract,Solidago Virgaurea (Goldenrod) Extract, Allantoin, Bisabolol, Tocopheryl Acetate, lnulin lauryl Carbamate, Sodium Polyacryloyldimethyl Taurate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum,Silica,Ethylhexyl Methoxycrylene, 1,2-Hexanediol,Citric Acid,Ethylhexylglycerin, Phenoxyethanol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 ML NDC 68577-232-02 TubeTube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 6877-232

BottleBottleCartonCarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrfy.io/LjsriqULu8SOFIEPA_SP.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-232-01SOFIE PAVITT FACE SPF 3050 mL in 1 BOTTLE, PUMPCREAM501
68577-232-01SOFIE PAVITT FACE SPF 301 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-23268577-232-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID2968PHW8QPIACT
CLOVEK48IKT5321IACT
AVOBENZONEG63QQF2NOXACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM POLYACRYLOYLDIMETHYL TAURATENG5NG5733TIACT
BISABOLOL24WE03BX2TIACT
ECTOIN7GXZ3858RYIACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
SILICAETJ7Z6XBU4IACT
XANTHAN GUMTTV12P4NEEIACT
HOMOSALATEV06SV4M95SACTIB
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
INULIN LAURYL CARBAMATE48RFF58ESGIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
ALLANTOIN344S277G0ZIACT
NIACINAMIDE25X51I8RD4IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT

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
57c50393-03ad-57dc-e063-6294a90a19474af633fb-0d78-c822-e063-6294a90a24672026-07-29WarningsExact identifier
spl set id: 4af633fb-0d78-c822-e063-6294a90a2467

Reported adverse events (FAERS/openFDA)#

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