Otc - Active Ingredient
Active ingredients
Ethylhexyl Methoxycinnamate 7%
Homosalate 6 %
Polysilicone-15 5%
Octocrylene 5%
Butyl Methoxydibenzoylmethane 2%
Sunscreen Lip Balm Lipstick
FDA Label NDC 84066-101
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 Tata Biotechnology Co., Ltd. for the product Sunscreen Lip Balm (NDC 84066-101). 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, inactive ingredient, otc - questions, indications & usage, warnings, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Inactive Ingredient
lnactive ingredients：Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax，Fragrance, Tocopherol， Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil，12-Hexanediol, Citric Acid
Otc - Questions
Questions or comments?
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Indications & Usage
helps prevent sumburn
if used as directed with other sun protection measures, (see Directions) decreases therisk of skin cancer and early skin aging caused by the sun
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison
Control Center immediately.
Dosage & Administration
Directions
apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts,pants,hats and sunglasses
Storage And Handling
Other information protect this product from excessive heat and direct sun
* Please review the disclaimer below.
