ALOHA MINERAL BLOCK-BRUSH ON MINERAL POWDER SUNSCREEN SPF50- spf50 powder powder

Aloha mineral block-BRUSH ON MINERAL Powder SUNSCREEN SPF50 by

Drug Labeling and Warnings

Aloha mineral block-BRUSH ON MINERAL Powder SUNSCREEN SPF50 by is a Otc medication manufactured, distributed, or labeled by Aopline Health Industry Technology (Guangzhou) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium dioxide-19.5%

Zinc oxide-24%

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

Flammable. Do not spray near heat sparks, sources of ignition, or flames.

Do not use

WHEN USING

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.

Stop use

Stop use and ask a doctor if rash occurs.

ASK DOCTOR

Children under 6 months of age: ask a doctor.

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

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water

resistant sunscreen if swimming or sweating.

Other Information

Protect this product in this container from excessive heat and direct sun.

Inactive Ingredients

Mica, Vinyl Dimethicone/Methicone,Silsesquioxane Crosspolymer, Sodium Benzoate. Potassium Sorbate,Coconut Scent, Kaolin, Tocopherol,Rubus idaeus (Raspberry) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil,Oryza Sativa (Rice) Powder,Silica Dimethyl Silylate, Mango Scent,Magnesium Stearate, Stearic Acid,Camellia Sinensis Extract, Aloe Barbadensis Leaf Powder,Chrysanthellum Indicum Extract,Lophatherum Gracile Leaf Powder,Lavandula Angustifolia (Lavender) Oil,Ci 77492, Ci 77491, Ci 77499

Package Label

label 82723-006-01

INGREDIENTS AND APPEARANCE

ALOHA MINERAL BLOCK-BRUSH ON MINERAL POWDER SUNSCREEN SPF50 
spf50 powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82723-006
Route of Administration	TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	19.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
COCONUT (UNII: 3RT3536DHY)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CARROT SEED OIL (UNII: 595AO13F11)
RICE BRAN (UNII: R60QEP13IC)
KAOLIN (UNII: 24H4NWX5CO)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MANGO (UNII: I629I3NR86)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)
LOPHATHERUM GRACILE LEAF (UNII: R417138GE9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82723-006-01	6 g in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/21/2024

Labeler - Aopline Health Industry Technology (Guangzhou) Co., Ltd. (715076108)

Establishment
Name	Address	ID/FEI	Business Operations
Aopline Health Industry Technology (Guangzhou) Co., Ltd.		715076108	manufacture(82723-006)