Otc - Active Ingredient
AVOBENZONE G63QQF2NOX 3.0%
OCTISALATE 4X49Y0596W 5.0%
OCTOCRYLENE 5A68WGF6WM 7.0%
HOMOSALATE V06SV4M95S 9%
Sunscreen Glowing
FDA Label NDC 82723-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aopline Health Industry Technology (guangzhou) Co., Ltd. for the product Sunscreen Glowing (NDC 82723-010). 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, otc - purpose, otc - do not use, otc - keep out of reach of children, otc - stop use, otc - when using, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Otc - Do Not Use
For external use only Do not use on damaged !i or broken skin.
When using this product keep out of eyes.Rise with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. lf swallowed, get medical help or contact a Poison ControlCenter right away
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison ControlCenter right away
Otc - Stop Use
When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Otc - When Using
Directions
Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours or after 80 minutes of swimming or sweating. Sun Protection Measures: $pending time in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPfof 15 or higher and other sun protection measures including: limit time in the sun, especiallyfrom 10 a.m.-2 pm, and wear long-sleeved shirts, pants, hats, and sunglasses. Childrenunder 6 months of age ask a doctor.
Inactive Ingredient
WATER
BUTYLOCTYL SALICYLATE
NEOPENTYL GLYCOL DIHEPTANOATE
MICA
CI 77891
BUTYL METHOXYDIBENZOYLMETHANE
GLYCERIN
PROPYLENE GLYCOL
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
CETEARYL ALCOHOL
COCO-GLUCOSIDE
GLYCERYL STEARATE
PEG-100 STEARATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
SILICA
POTASSIUM CETYL PHOSPHATE
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
CETEARYL ALCOHOL
HYDROXYACETOPHENONE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
CI 77492
TRIETHOXYCAPRYLYLSILANE
DISODIUM EDTA
CI 77491
CI 77499
Indications & Usage
Uses
Helps prevent sunburn.lf used as directed with other sun protection measures (see Directions), decreases therisk of skin cancer and early skin aging causedby the sun.
Warnings
For external use only. Do not use on damagedor broken skin.
When using this product keep out of eyes.nse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. lf swallowed, get medical help or contact a Poison ControlCenter right away
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
Reapply: at least every 2 hours or after 80 minutes of swimming or sweating.
* Please review the disclaimer below.
