Active Ingredients Purpose
Octocrylene 10%.................... Sunscreen
Titanium Dioxide 5.1%............ Sunscreen
Avobenzone 4%..................... Sunscreen
Lightening High Sun Protection Cream
FDA Label NDC 20151-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Casmara Cosmetics, Sa for the product Lightening High Sun Protection Cream (NDC 20151-105). 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 active ingredients purpose, warnings, questions or comments?, other information, directions, dosage & administration, uses, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
SUN ALERT: The sun causes skin damages. Regular use of sunscreens over the years may reduce the risks of skin damages, some types of skin cancer, and other harmful effects due to the sun
For external use only, not to be swallowed.
Do not use on damaged or broken skin.
When using this product keep our of the eyes. Rinse with water to remove.
DIscontinue uses if signs or irritationsor rash appears. If irritation or rash persists, consult with a doctor.
Keep out of reach of children.
Children under 6 months: as a doctor.
Stop use and ask a doctor if rash occurs
Children under 6 months: ask a doctor
Keep out of reach of children
Questions Or Comments?
+ 34 961 501 999 M-F 9:00 am to 5:00 pm
Other Information
. keep the product in a cool and dry place
Directions
- adults and childrens 6 months of age and over: apply generaously before sun exposure. Reapply after swiming, excessive sweating or anytime after towel drying. Children under 2 years of age or less should use sunscreen products with a minium of SPF 4
- children under 6 months of age, consult with a doctor
Dosage & Administration
- adults and childrens 6 months of age and over: apply generaously before sun exposure. Reapply after swiming, excessive sweating or anytime after towel drying. Children under 2 years of age or less should use sunscreen products with a minium of SPF 4
- children under 6 months of age, consult with a doctor
Uses
- provides high protection against sunburns
- sunscreen to help prevent sunburns. FIlters the sun rays to help prevent the skin damages
- provides high protection against sunburns
- sunscreen to help prevent sunburns. FIlters the sun rays to help prevent the skin damages
Inactive Ingredients
Water, Glycerin, Butylene glycol dicaprylate/dicaprate, Ethylhexyl salicylate, Alcohol denat, Bemotrizinol, Polysilicone-15, Cetyl alcohol, Glyceryl stearate, Phenoxyethanol, PEG-75 stearate, Silica, Xanthan gum, Butylene glycol, Ceteth-20, Steareth-20, Dimethicone, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Fragrance, Soybean protein
Package Label
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