SOFIE PAVITT FACE SPF 30- avobenzone, homosalate, octisalate cream

SOFIE PAVITT FACE SPF 30 by

Drug Labeling and Warnings

SOFIE PAVITT FACE SPF 30 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA., CORP, COSMAX USA, CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Avobenzone 3.00%
Homosalate 7.00%
Octisalate 5.00%

PURPOSE

Purpose

Sunscreen

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

WARNINGS

Warnings

Do not use

• on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

• skin rash occurs

Keep out of reach of children.

DIRECTIONS

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

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.

PRINCIPAL DISPLAY PANEL

10 ML NDC: 68577-232-02

PRINCIPAL DISPLAY PANEL

NDC: 6877-232

INGREDIENTS AND APPEARANCE

SOFIE PAVITT FACE SPF 30 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
CLOVE (UNII: K48IKT5321)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
BISABOLOL (UNII: 24WE03BX2T)
ECTOIN (UNII: 7GXZ3858RY)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
SILICA (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALLANTOIN (UNII: 344S277G0Z)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-232-01	1 in 1 CARTON	02/28/2026
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/28/2026

Labeler - COSMAX USA., CORP (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORP		010990210	manufacture(68577-232)