Otc - Active Ingredient
Titanium Dioxide 5.14%
Zinc Oxide 5.74%
Biossance Squalane And Daily Mineral Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 84448-801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Thg Beauty Usa Llc for the product Biossance Squalane And Daily Mineral Sunscreen Broad Spectrum Spf 50 (NDC 84448-801). 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 - stop use, otc - when using, 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 sunburn.
- If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by exposure to the sun.
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.
Dosage & Administration
- Shake well before use.
- Apply generously to face and neck 15 minutes before sun exposure.
- Use water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Children under 6 months of age: Ask a doctor.
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PENTYLENE GLYCOL, GLYCERIN, SQUALANE, SILICA, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALUMINA, HYDROGENATED LECITHIN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PROPANEDIOL, STEARIC ACID, NIACINAMIDE, JOJOBA ESTERS, 1,2-HEXANEDIOL, ALLANTOIN, TOCOPHERYL ACETATE, XANTHAN GUM, GLYCINE SOJA (SOYBEAN) OIL, SODIUM HYALURONATE, TOCOPHEROL, GLYCOGEN, ETHYLHEXYLGLYCERIN, CAPRYLHYDROXAMIC ACID, SORBITAN ISOSTEARATE, CITRIC ACID, SODIUM HYDROXIDE
Package Label.Principal Display Panel
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