Otc - Active Ingredient
HOMOSALATE 10%
OCTOCRYLENE 5%
ETHYLHEXYL SALICYLATE 4.5%
BUTYL METHOXYDIBENZOYLMETHANE 3%
BENZOPHENONE-3 3%
Watery Texture Sunscreen
FDA Label NDC 84257-102
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 Maitelin Information Technology Co., Ltd. for the product Watery Texture Sunscreen (NDC 84257-102). 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 - keep out of reach of children, indications & usage, warnings, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
Helps prevent sunburn
If used as directed and with other sun protec-tion measures(see Directions), decreases therisk of skin cancer and early skin aging causedby the sun.
Warnings
For external use only.
Don't use this product, if you are pregnant or nursing.
Keep out of reach of children.
Do not use on damaged or broken skin.
In case of discomfort during use, cean and stop using.
Avoid contact with eyes, in case of contact with eyes, rinse with clean water.
Dosage & Administration
Apply onto face as last step of basic skin care.
Apply 15 minutes before sun exposure, pat lightly until fully absorbed.
Reapply:
at every 2 hours for long-time sun exposure.
after 40 minutes of swimming or sweating.
Sun Protection Measures: Spending time in the sun increases the risk of skin cancer and earlyskin aging. To decrease this risk, regularly use asunscreen with a broad spectrum SPF value of15 or higher and take other sun protection mea-sures, including:Limit time in the sun, especially between 10a.m. and 2 p.m.
.Wear long-sleeved shirts, long pants, hats and sunglasses.
.Children under 6 months of age: ask a doctor.
Storage And Handling
Store at room temperature, away from directsunlight.
Inactive Ingredient
WATER
PROPYLENE GLYCOL
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE
TRILAURETH-4 PHOSPHATE
C12-15 ALKYL BENZOATE
NEOPENTYL GLYCOL DIHEPTANOATE
POTASSIUM CETYL PHOSPHATE
BUTYLENE GLYCOL
DIMETHICONE
1,2-HEXANEDIOL
HYDROXYACETOPHENONE
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
CAPRYLIC/CAPRIC TRIGLYCERIDE
CETYL PEG/PPG-10/1 DIMETHICONE
TOCOPHERYL ACETATE
HYDROXYPROPYL TETRAHYDROPYRANTRIOL
NIACINAMIDE
BISABOLOL
XANTHAN GUM
BIFIDA FERMENT FILTRATE
PANTHENOL
ARTEMISIA ANNUA EXTRACT
CRITHMUM MARITIMUM CALLUS CULTURE FILTRATE
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
OAT β-GLUCAN
ETHYLHEXYLGLYCERIN
ZINC OXIDE
HYDROLYZED SODIUM HYALURONATE
METHYLSILANOL TRI-PEG-8 GLYCERYL COCOATE
POLYQUATERNIUM-7
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE
TRIALKYLAMINES
TRIALKANOLAMINES AND THEIR SALTS
TRIETHOXYCAPRYLYLSILANE
CENTELLA ASIATICA EXTRACT
PHENOXYETHANOL
PEG-7 GLYCERYL COCOATE
FRAGRANCE
Package Label.Principal Display Panel
Label (001)
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