Erborian - Bb Creme Nude Spf20 Cream
FDA Label NDC 10345-902

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires M&l for the product Erborian - Bb Creme Nude Spf20 (NDC 10345-902). 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, uses, warnings, keep out of reach of children, directions, inactive ingredients, package labeling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients


Octinoxate 3.00%
Titanium dioxide 6.28%
Zinc oxide 1.92%

Purpose

sunscreen

Uses

-Helps prevent sunburn
-If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

-For external use only. Do not use on damaged or broken skin

-When using this product keep out of eyes. Rinse with water to remove

-Stop use and ask a doctor if rash occurs.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

For sunscreen use:
-Apply liberally 15 minutes before sun exposure
-Reapply at least every 2 hours
-Use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
-Limit time in the sun, especially from 10 a.m. –2 p.m.
-Wear long-sleeved shirts, pants, hats and sunglasses
-Children under 6 months of age: Ask a doctor

Inactive Ingredients

Aqua/water - cyclomethicone- glycerin hexyl laurate - dipropylene glycol - peg-10 dimethicone- talc - dimethicone- isoeicosane-disteardimonium hectorite - betaine -centella asiatica extract- polygonum cuspidatum root extract - scutellaria baicalensis root extract - camellia sinensis leaf extract - glycyrrhiza glabra (licorice) root extract - chamomilla recutita (matricaria) flower extract - portulaca oleracea extract - rosmarinus officinalis (rosemary) leaf extract - hydrogenated starch hydrolysate - ethylhexylglycerin - tocopheryl acetate - magnesium sulfate - silica - glycosyl trehalose - aluminum hydroxide - palmitic acid - stearic acid - butylene glycol - phenoxyethanol - vinyl dimethicone/methicone silsesquioxane crosspolymer - acrylates/dimethicone copolymer - dimethicone/vinyl dimethicone crosspolymer -methicone - CI 77492/iron oxides - CI 77499/iron oxides - CI 77491/iron oxides

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