Eau Thermale Avene Hydrating Sunscreen SPF 50

Manufacturer: Pierre Fabre Dermo-Cosmetique USA, Inc.
Effective date: 2019-09-10
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:12:40

Label at a glance#

ProductEau Thermale Avene Hydrating Sunscreen SPF 50

Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Label structure9 sections

Indications and uses

helps 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

shake well before use apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 of 15 or higher and other sun protection measures including: ...

Contacts and useful links#

Websitewww.aveneusa.com

www.aveneusa.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps 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

For external use only

OTC - DO NOT USE SECTION

Do not use on damage or broken skin

OTC - WHEN USING SECTION

When using this product

Keep out of eyes. Rinse eyes with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before use
apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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 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

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Isononyl Isononanoate, Glycerin, Isododecane, Cetyl Dimethicone, Isohexadecane, Silica, Styrene/Acrylates Copolymer, Dimethicone, Polyester-7, Polyester-8, Neopentyl Glycol Diheptanoate, Ethylhexyl Methoxycrylene, Arachidyl Glucoside, Tocopheryl Acetate, Behenyl Alcohol, Arachidyl Alcohol, Sorbitan Isostearate, Polyglyceryl-3 Distearate, Steareth-100, Sorbitol, Phenoxyethanol, Ethylhexylglycerin, Xanthan Gum, Oleic Acid, Lecithin, Disodium EDTA, Sodium Polyacrylate, Steareth-2, Mannan, p-Anisic Acid.

Questions or comments?

OTC - QUESTIONS SECTION

visit www.aveneusa.com or call toll-free 1-866-41-AVENE (28363)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ARACHIDYL ALCOHOL	INACTIVE INGREDIENT	1QR1QRA9BU	1
ARACHIDYL GLUCOSIDE	INACTIVE INGREDIENT	6JVW35JOOJ	1
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER	INACTIVE INGREDIENT	V5RS026Q0H	1
CETYL DIMETHICONE 25	INACTIVE INGREDIENT	U4AS1BW4ZB	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
ETHYLHEXYL METHOXYCRYLENE	INACTIVE INGREDIENT	S3KFG6Q5X8	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
ISODODECANE	INACTIVE INGREDIENT	A8289P68Y2	1
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	1
ISONONYL ISONONANOATE	INACTIVE INGREDIENT	S4V5BS6GCX	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	1
NEOPENTYL GLYCOL DIHEPTANOATE	INACTIVE INGREDIENT	5LKW3C543X	1
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	1
P-ANISIC ACID	INACTIVE INGREDIENT	4SB6Y7DMM3	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYESTER-7	INACTIVE INGREDIENT	0841698D2F	1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)	INACTIVE INGREDIENT	T9296U138P	1
POLYGLYCERYL-3 DISTEARATE	INACTIVE INGREDIENT	ZI1LK470XV	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	1
SORBITAN ISOSTEARATE	INACTIVE INGREDIENT	01S2G2C1E4	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
STEARETH-100	INACTIVE INGREDIENT	4OH5W9UM87	1
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1
YEAST MANNAN	INACTIVE INGREDIENT	91R887N59P	1

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

Eau Thermale Avene Hydrating Sunscreen SPF 50
Avobenzone, Homosalate, Octisalate, Octocrylene
WATER
ISONONYL ISONONANOATE
GLYCERIN
ISODODECANE
CETYL DIMETHICONE 25
ISOHEXADECANE
SILICON DIOXIDE
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER
DIMETHICONE
POLYESTER-7
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
NEOPENTYL GLYCOL DIHEPTANOATE
ETHYLHEXYL METHOXYCRYLENE
ARACHIDYL GLUCOSIDE
.ALPHA.-TOCOPHEROL ACETATE
DOCOSANOL
ARACHIDYL ALCOHOL
SORBITAN ISOSTEARATE
POLYGLYCERYL-3 DISTEARATE
STEARETH-100
SORBITOL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
XANTHAN GUM
OLEIC ACID
LECITHIN, SOYBEAN
EDETATE DISODIUM
SODIUM POLYACRYLATE (8000 MW)
STEARETH-2
YEAST MANNAN
P-ANISIC ACID
AVOBENZONE
HOMOSALATE
OCTISALATE
OCTOCRYLENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67015-0791	67015-0791-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ISONONYL ISONONANOATE	S4V5BS6GCX	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISODODECANE	A8289P68Y2	IACT
CETYL DIMETHICONE 25	U4AS1BW4ZB	IACT
ISOHEXADECANE	918X1OUF1E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER	V5RS026Q0H	IACT
DIMETHICONE	92RU3N3Y1O	IACT
POLYESTER-7	0841698D2F	IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)	T9296U138P	IACT
NEOPENTYL GLYCOL DIHEPTANOATE	5LKW3C543X	IACT
ETHYLHEXYL METHOXYCRYLENE	S3KFG6Q5X8	IACT
ARACHIDYL GLUCOSIDE	6JVW35JOOJ	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
DOCOSANOL	9G1OE216XY	IACT
ARACHIDYL ALCOHOL	1QR1QRA9BU	IACT
SORBITAN ISOSTEARATE	01S2G2C1E4	IACT
POLYGLYCERYL-3 DISTEARATE	ZI1LK470XV	IACT
STEARETH-100	4OH5W9UM87	IACT
SORBITOL	506T60A25R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
XANTHAN GUM	TTV12P4NEE	IACT
OLEIC ACID	2UMI9U37CP	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
STEARETH-2	V56DFE46J5	IACT
YEAST MANNAN	91R887N59P	IACT
P-ANISIC ACID	4SB6Y7DMM3	IACT
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 309 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARETH-100	STEARETH-100	4OH5W9UM87	OINTMENT / TOPICAL		86 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
OLEIC ACID	OLEIC ACID	2UMI9U37CP	TABLET, COATED / ORAL	0.72 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
OLEIC ACID	OLEIC ACID	2UMI9U37CP	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
DOCOSANOL	DOCOSANOL	9G1OE216XY	AEROSOL, FOAM / TOPICAL	1.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
OLEIC ACID	OLEIC ACID	2UMI9U37CP	GEL, METERED / TOPICAL		88 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
923580c7-e63d-4aa7-e053-2995a90a3c3b			042cd302-03be-458f-96e9-622fb8ec9355	2019-09-10	Warnings	Exact identifier spl id: 923580c7-e63d-4aa7-e053-2995a90a3c3b spl set id: 042cd302-03be-458f-96e9-622fb8ec9355

Reported adverse events (FAERS/openFDA)#

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