MIDHA RICE DAILY MOISTURE SUN CREAM- avobenzone, homosalate, octisalate, octocrylene cream

Drug Labeling and Warnings

Drug Details [pdf]

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

Active Ingredients

Avobenzone 2.8%
Homosalate 7.3%
Octisalate 4.8%
Octocrylene 9.5%

Warnings

. For external use only
. Do not use on damaged or broken skin
. Stop use and ask a doctor if rash occurs
. when using this product, keep out of eyes. Rinse with water to remove

Directions

. Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 or higher and other sun protection measures including:
1) Limit time in the sun, especially from 10 am to 2 pm.
2) Wear long-sleeve shirts, pants, hats, and sunglasses
. Children under 6 months of age : Ask a doctor.

Other Information

. protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Cetearyl Glucoside, Pentylene Glycol, Sorbitan Olivate, Poloxamer 338, Glyceryl Stearate SE, Benzyl Glycol, Carbomer, Arginine, Polyacrylate Crosspolymer-6, PPG-51/SMDI Co polymer, Ethylhexyl Olivate, Methylpropanediol, Cetearyl Alcohol, Xanthan Gum, Oryza Sativa (Rice) Bran Water, Sodium Acrylates Copolymer, Ethylhexylglycerin, Poly glyceryl-4 Oleate, 1,2-Hexanediol, Caprylyl Glycol, Inula Britannica Flower Extract, Rumex Crispus Root Extract, Camellia Sinensis Leaf Extract, Koenigia Alpina Extract, Glycerin, Steareth-30, Oryza Sativa (Rice) Bran Extract, Rice Ferment Filtrate (Sake), Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Saccharomyces/Rice Bran Ferment, Lactobacillus/Rice Ferment

Keep out of reach of children.

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

PRINCIPAL DISPLAY PANEL

Rice UV Protection Moisturizing

Rice daily moisture sun cream

SPF 50

Broad Spectrum sunscreen

50 ml / 1.69 fl.oz.

INGREDIENTS AND APPEARANCE

MIDHA RICE DAILY MOISTURE SUN CREAM 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87417-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	95 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER (UNII: 0A5MM307FC)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLOXAMER 338 (UNII: F75JV2T505)
BENZYL GLYCOL (UNII: 06S8147L47)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C)
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ORYZA SATIVA (RICE) GERM OIL (UNII: D4H5GGS5JF)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARETH-30 (UNII: 5776GCL1DG)
RICE GERM (UNII: 7N2B70SFEZ)
PENTANEMA BRITANNICA FLOWER (UNII: 9AJ0R02YE7)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
GLYCERIN (UNII: PDC6A3C0OX)
RICE BRAN, DEFATTED (UNII: H6597RO5A2)
ARGININE (UNII: 94ZLA3W45F)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
XANTHAN GUM (UNII: TTV12P4NEE)
GRAPE SEED EXTRACT (UNII: RDS2V6DVY5)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87417-100-02	1 in 1 BOX	04/08/2026
1	NDC: 87417-100-01	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	04/08/2026

Labeler - MIDHA Cosmetic Co.,Ltd. (694836377)

Registrant - MIDHA Cosmetic Co.,Ltd. (694836377)

Establishment
Name	Address	ID/FEI	Business Operations
Rebom Co.,Ltd		695951708	manufacture(87417-100)