Anna Lotan Lightly Tinted Mineral Day Cream Broad Spectrum Spf 30 Cream
FDA Label NDC 76446-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anna Lotan Ltd for the product Anna Lotan Lightly Tinted Mineral Day Cream Broad Spectrum Spf 30 (NDC 76446-300). 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 drug facts, active ingredients, purpose:, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Titanium Dioxide 7.75%
Zinc Oxide 10.0%
Purpose:
Sunscreen
Uses
• helps prevent sunburn
• if used as directed with other sun protective 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
• apply to all skin exposed to the sun
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or sweating
• for children under 6 months: Ask a doctor
• 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 sun from 10 a.m.- 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
Other Information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredients
water (aqua), caprylic/capric triglyceride, butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, aluminum stearate, carthamus tinctorius oleosomes, polyhydroxystearic acid, aloe barbadensis leaf juice, polygonum aviculare extract, tocopheryl acetate, perilla frutescens extract, vitis vinifera fruit cell extract, lepidium sativum sprout extract, squalane, cetearyl alcohol, isononyl isononanoate, coco-glucoside, pentylene glycol, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, simmondsia chinensis (jojoba) seed oil, stearic acid, sucrose stearate, phenethyl alcohol, tetrahexyldecyl ascorbate, glyceryl caprylate, ethylene/propylene/styrene copolymer, sorbitan oleate, polyglyceryl-2 caprate, propanediol, alumina, arachidyl alcohol, iron oxides (CI 77492, CI 77491, CI 77499).
Questions Or Comments?
(781) 281-0954
Packaging
Label (7644630050 2)
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