Sunscreen SPF 50 by Guangzhou Ariel Biotech Co., Ltd. / GUANGZHOU ARIEL BIOTECH CO., LTD SUNSCREEN SPF 50 cream

Sunscreen SPF 50 by

Drug Labeling and Warnings

Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Guangzhou Ariel Biotech Co., Ltd., GUANGZHOU ARIEL BIOTECH CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS :

ACTIVE INGREDIENTSPURPOSEOCTOCRYLENE8%…………Sunscreen

ETHYLHEXYL SALICYLATE 5%.…………Sunscreen

ZINC OXIDE 3%.....Sunscreen

DESCRIPTION

Use:

Helps prevent sunburn

WARNINGS

Warnings:

WARNINGSFor external use only.Store at room temperatureDiscontinue use if redness or irritation occurs

DO NOT USE

DO NOT USE
on damaged or broken skin

WHEN USING

WHEN USING SECTION:

When using this product, avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

Discontinue use if any irritation or adverse reaction occurs.

INSTRUCTIONS FOR USE

WHEN USING SECTION
When using this product, avoid contact with eyes. lf contact occursrinse thoroughly with water.
Discontinue use if any irritation or adverse reaction occurs

INACTIVE INGREDIENT

INACTIVE INGREDIENTS
1,2-HEXANEDIOL, AMINOMETHYL PROPANOL, AQUA, ARACHIDYL ALCOHOLARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BETAINE, BUTYLMETHOXYDIBENZOYLMETHANE, BUTYLENE GLYCOL, CENTELLA ASIATICAEXTRACT, CETEARYL ALCOHOL, CETYL PHOSPHATE, CYCLOHEXASILOXANECYCLOPENTASILOXANE, DISODIUM EDTA, ECTOIN, GLUCOSE, GLYCERIN,GLYCERYL POLYACRYLATE, HYDROXYACETOPHENONE, HYDROXYETHYLACRYLATE / SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, JASMINUMSAMBAC (JASMINE) FLOWER EXTRACT, NEOPENTYL GLYCOL DIHEPTANOATENIACINAMIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID, POLYACRYLATE-13.POLYISOBUTENE, POLYSILICONE-11, POLYSORBATE 20, POLYSORBATE 60.PROPANEDIOL, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, SORBITANISOSTEARATE, STEPHANIA TETRANDRA EXTRACT, TARAXACUM OFFICINALE(DANDELION) LEAF EXTRACT, XANTHAN GUM.

OTHER SAFETY INFORMATION

Manufactured by Guangzhou Ariel Biotech Co., Ltd

No. 79 Ruihe Road, Huangpu District, Guangzhou,Guangdong, China

PURPOSE

Sunscreen

DOSAGE & ADMINISTRATION

DIRECTIONS
1.Squeeze an appropriate amount of sunscreen into the palm of yourhand and spread it evenly on the face. Don't forget that sunscreen isalso required on the neck and ears.2. Wait 5-10 minutes for the sunscreen to absorb fully.3. For outdoor activities, sunscreen must be reapplied every 2-3hours or after swimming or sweating.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

WHEN USING SECTION
When using this product, avoid contact with eyes. lf contact occurs.
rinse thoroughly with water.
Discontinue use if any irritation or adverse reaction occurs

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 50 
sunscreen spf 50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84148-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ECTOINE (UNII: 7GXZ3858RY)
TARAXACUM OFFICINALE (UNII: 39981FM375)
BETAZINE (UNII: AIK06F3ZZY)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ENSULIZOLE (UNII: 9YQ9DI1W42)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AVOBENZONE (UNII: G63QQF2NOX)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE 7 (UNII: KCK5L8VU47)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
STEPHANIA TETRANDRA WHOLE (UNII: 7S7TV2F4XC)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
SAURURUS CHINENSIS FLOWER (UNII: 9L0SCP0SKZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84148-002-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/12/2024

Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU ARIEL BIOTECH CO., LTD		402818771	manufacture(84148-002)