ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN by

Drug Labeling and Warnings

ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by The Founders Inc., ENGLEWOOD LAB, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.0%

Homosalate 7.0%

Octisalate 5.0%

Octocrylene 5.0%

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

■ 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

■ rash occurs

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

■ Reapply:

■ after 80 minutes of swimming or sweating

■ immediately after towel drying

■ at least every 2 hours

■ Children under 6 months of age: Ask a doctor

■ 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

Inactive ingredients

Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Cetearyl Alcohol, Niacinamide, Sodium Stearoyl Glutamate, Ammonium Polyacryloyldimethyl Taurate, Hydroxyacetophenone, Phenoxyethanol, Tocopheryl Acetate, Panthenol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Xanthan Gum, 1,2-Hexanediol, Sodium Hyaluronate

Questions?

+1-888-899-9083

Monday–Friday (9 a.m.–5 p.m. EST)

www.anua.us

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84610-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
NIACINAMIDE (UNII: 25X51I8RD4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84610-200-01	1 in 1 CARTON	04/30/2025
1		50 mL in 1 TUBE; 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	04/30/2025

Labeler - The Founders Inc. (695015866)

Registrant - The Founders Inc. (695015866)

Establishment
Name	Address	ID/FEI	Business Operations
ENGLEWOOD LAB, INC.		172198223	manufacture(84610-200)