Otc - Active Ingredient
ACTIVE INGREDIENTS :
ACTIVE INGREDIENTSPURPOSEOCTOCRYLENE8%…………Sunscreen
ETHYLHEXYL SALICYLATE 5%.…………Sunscreen
ZINC OXIDE 3%.....Sunscreen
Sunscreen Spf 50 Cream
FDA Label NDC 84148-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ariel Biotech Co., Ltd. for the product Sunscreen Spf 50 (NDC 84148-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, description, warnings, otc - do not use, otc - when using, instructions for use, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
Use:
Helps prevent sunburn
Warnings
Warnings:
WARNINGSFor external use only.Store at room temperatureDiscontinue use if redness or irritation occurs
Otc - Do Not Use
DO NOT USE
on damaged or broken skin
Otc - 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
Otc - 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.
Otc - 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
Package Label.Principal Display Panel
84148-002-01 (Label)
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