Otc - Active Ingredient
ETHYLHEXYL METHOXYCINNAMATE 6%
OCTOCRYLENE 4%
TITANIUM DIOXIDE 2%
Sunscreen Spf50 Cream
FDA Label NDC 85998-001
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 Tinsun Biotechnology Company Limited for the product Sunscreen Spf50 (NDC 85998-001). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Block or absorb ultraviolet rays to preventskin from developing erythema, tanningand aging due to sun exposure
Warnings
Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd
Otc - Do Not Use
Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd
Otc - When Using
Ask a doctor before use if
Photosensitivity skin diseases or taking certain photosensitivity medications
Otc - Stop Use
Stop use and ask a doctor if
Redness,itching, peeling, or stinging occurs after applying sunscreen
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN SECTION
Dosage & Administration
Take an appropriate amount of sunscreenon the palm of your hand and applyevenly to the face, neck, arms and otherareas exposed to the sun.
Inactive Ingredient
WATER
ISONONYL ISONONANOATE
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL
GLYCERIN
BUTYLENE GLYCOL
CYCLOPENTASILOXANE
STEARETH-2
STEARETH-21
CAPRYLIC/CAPRIC TRIGLYCERIDE
TOCOPHERYL ACETATE
ALOE BARBADENSIS LEAF EXTRACT
PORTULACA OLERACEA EXTRACT
POLYSORBATE 80
RUTIN
BETA-GLUCAN
1,2-HEXANEDIOL
HYDROXYACETOPHENONE
XANTHAN GUM
ORYZANOL
BISABOLOL
SODIUM HYALURONATE
ALLANTOIN
DISODIUM EDTA
AROMA
Package Label.Principal Display Panel
Label1 (Label1)
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