Active Ingredients
Zinc Oxide
Titanium Dioxide
Spf 50
FDA Label NDC 58133-651
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Spf 50 (NDC 58133-651). 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, sun alert:, uses, caution, warnings, directions: fda recommends, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Sunscreen
Sun Alert:
Limiting sun exposure, wearing protective clothing, and using broad spectrum sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Uses
Helps prevent sunburn. Used as directed with other sun proctection measures, decreases skin cancer risk and early skin aging, caused by the sun.
Caution
May stain some fabrics. Keep out of direct sunlight and excessive heat. Some natural seperation may occur. Shake well before using.
Warnings
For external use only. Do not ingest. Keep out of eyes; rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact poison control.
Directions: Fda Recommends
- Applying 15 minutes before sun exposure
- Using a water resistant sunscreen if swimming or sweating
- Reapplying at least every 2 hours
- For children under 6 months: consult pediatrician
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Beeswax, Butyrospermum parkii (Shea) Butter, C12-15 Alkyl Benzoate, Candelilla (Euphorbia Cerifera) Wax, Carthamus tinctorius (Safflower) Seed Oil, Castor Oil Phosphate, Chamomilla recutita (Matricaria) Flower Extract, Cocos nucifera (Coconut) Oil, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus annuus (Sunflower) Seed Oil, Iron Oxides (CI 77492, CI 77491, CI 77499), Lavandula angustifolia (Lavender) Oil, Mangifera indica (Mango) Seed Butter, Octyldodecanol, Olea europaea (Olive) Fruit Oil, Persea gratissima (Avocado) Oil, Prunus amygdalus dulcis (Sweet Almond Oil), Sorbitan Oleate, Symphytum officinale (Comfrey) Leat Extract, Theobroma cacao (Cocoa) Seed Butter, Tocopherol, Triethoxycaprylylsiloxane
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