ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN by

Drug Labeling and Warnings

ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by THE AVON COMPANY, fmg Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE 2.7%

HOMOSALATE 9.0%

OCTISALATE 4.5%

OCTOCRYLENE 9.0%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• 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.
• wear long-sleeved shirts, pants, hats, and sunglasses

Other information

• protect the product in this container from excessive heat and direct sun
• the product may stain certain types of fabrics

Inactive ingredients:

WATER, METHYL TRIMETHICONE, TRIETHYLHEXANOIN, BUTYLENE GLYCOL, GLYCERIN, C12-15 ALKYL BENZOATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYGLYCERYL-6 POLYRICINOLEATE, SORBITAN SESQUIOLEATE, 1,2-HEXANEDIOL, PANTHENOL, NIACINAMIDE, DISTEARDIMONIUM HECTORITE, DIPROPYLENE GLYCOL, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, DISTEARYLDIMONIUM CHLORIDE, TRISODIUM EDTA, PAEONOL, PAEONIA SUFFRUTICOSA BRANCH/FLOWER/LEAF EXTRACT, FRAGRANCE, CITRAL, CITRONELLOL, LIMONENE, GERANIOL, LINALOOL, TERPINOLENE, METHYL SALICYLATE, BETA-CARYOPHYLLENE, LINALYL ACETATE, SANTALOL, TERPINEOL, CANANGA ODORATA OIL/EXTRACT, CITRUS AURANTIUM BERGAMIA PEEL OIL, JUNIPERUS VIRGINIANA OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, SANTALUM ALBUM OIL, GERANYL ACETATE.

Questions?

1-800-FOR-AVON

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-2020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CITRAL (UNII: T7EU0O9VPP)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TRISODIUM EDTA (UNII: 420IP921MB)
PANTHENOL (UNII: WV9CM0O67Z)
PAEONOL (UNII: 3R834EPI82)
TERPINOLENE (UNII: N9830X5KSL)
METHYL SALICYLATE (UNII: LAV5U5022Y)
LINALYL ACETATE (UNII: 5K47SSQ51G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BETA-CARYOPHYLLENE (UNII: BHW853AU9H)
TERPINEOL (UNII: R53Q4ZWC99)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
GERANYL ACETATE (UNII: 3W81YG7P9R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
NUTMEG (UNII: AEE24M3MQ9)
GERANIOL (UNII: L837108USY)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
SANTALOL (UNII: 1DGG9VW8SA)
CANANGA ODORATA FLOWER OIL (UNII: 8YOY78GNNX)
SANTALUM ALBUM (SANDALWOOD) OIL (UNII: X7X01WMQ5F)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
LINALOOL (UNII: D81QY6I88E)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
CITRONELLOL (UNII: P01OUT964K)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-6 RICINOLEATE (UNII: 8X57R183N7)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-2020-1	1 in 1 CARTON	01/25/2026
1		80 mL in 1 BOTTLE; 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	01/25/2026

Labeler - THE AVON COMPANY (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
fmg Co.Ltd		690188305	manufacture(10096-2020)