Otc - Active Ingredient
Octocrylene 8%
Octisalate 5%
Titanium Dioxide 6%
Zinc Oxide 8%
Luxe Gloss Hydrating Lip Gloss Spf 35-guilty Pleasure Cream
FDA Label NDC 87911-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lale Cosmetics Llc for the product Luxe Gloss Hydrating Lip Gloss Spf 35-guilty Pleasure (NDC 87911-002). 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, 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
helps prevent sunbum.
if used as directed with other sun protection measures (seeDirections), decreases the risk ofskin cancer and early skin agingcaused 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. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
apply liberally 15 minutes before sun exposure.
reapply at least every 2 hours or after eating, drinking, or sun exposure.
Inactive Ingredient
Hydrogenated Polyisobutene,
Polybutene, C12-15 Alkyl
Benzoate, Microcrystalline Wax,
Acrylates/Octylacrylamide
Copolymer, Trimethylsiloxysilicate,
Silica Dimethyl Silylate, CI 77491,
CI15850, CI77492, CI77499,
Tocopherol, Bisabolol, Fragrance,
Aluminum Hydroxide,
Triethoxycaprylylsilane
Hydrogenated Polyisobutene,
Polybutene, C12-15 Alkyl
Benzoate, Microcrystalline
Wax, Acrylates/Octylacrylamide
Copolymer, Trimethylsiloxysili-
cate, Silica Dimethyl Silylate,
Tridecyl Trimellitate, CI 16035,
Tocopherol, CI 15850,
Bisabolol, Fragrance, CI 77499,
CI77491,CI77492
Hydrogenated Polyisobutene,
Polybutene, C12-15 Alkyl
Benzoate, Microcrystalline Wax,
Acrylates/Octylacrylamide
Copolymer, Trimethylsiloxysilicate,
Silica Dimethyl Silylate, CI 77491,
CI 15850, CI 77492, Tocopherol,
Bisabolol, Fragrance, CI 15985,
Aluminum Hydroxide,
Triethoxycaprylylsilane, Mica
Package Label.Principal Display Panel
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Label2 (Label2)
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Label3 (Label3)
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