ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN by

Drug Labeling and Warnings

ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by The Founders Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.0%

Homosalate 7.3%

Octisalate 5.0%

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

■ 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 product is 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

■ 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

■ reapply at least every 2 hours

■ use a water resistant sunscreen if swimming or sweating

Other Information

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

Inactive ingredients

Water, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Nylon-12, Silica, Sodium Acrylates Crosspolymer-2, 1,2-Hexanediol, Pentylene Glycol, Polyglyceryl-3 Distearate, Hydroxyethyl Urea, Cetearyl Olivate, Potassium Cetyl Phosphate, Butylene Glycol, Sorbitan Olivate, Cetyl Alcohol, Houttuynia Cordata Extract, Carbomer, Glycerin, Panthenol, Xanthan Gum, Glyceryl Stearate Citrate, Ethylhexylglycerin, Disodium EDTA, Acetyl Glucosamine, Sodium Hyaluronate, Cryptomeria Japonica Leaf Extract, Nelumbo Nucifera Leaf Extract, Saccharomyces Ferment, Hydroxyacetophenone, Cynanchum Atratum Extract, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Tocopherol, Dimethylsilanol Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Caprylyl Glycol, Hyaluronic Acid, Potassium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate

Questions ?

+82 1688-9407

Contact information

: www.anua.us

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84610-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)
SORBITAN OLIVATE (UNII: MDL271E3GR)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYALURONIC ACID (UNII: S270N0TRQY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PANTHENOL (UNII: WV9CM0O67Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CRYPTOMERIA JAPONICA LEAF (UNII: SCM4971GZQ)
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84610-100-01	1 in 1 CARTON	09/12/2024
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	09/12/2024

Labeler - The Founders Inc. (695015866)

Registrant - The Founders Inc. (695015866)