Active Ingredients
Zinc Oxide 14.0%
Mineral Sunscreen Spf30
FDA Label NDC 73418-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hello Bello for the product Mineral Sunscreen Spf30 (NDC 73418-104). 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, do not use on, flammable:, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
broken or damaged skin
Flammable:
Do not use near heat, flame, or while smoking
When Using This Product
Keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.
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
- Shake well before use
- Apply liberally 15 minutes before sun exposure
- Hold 4 to 6 inches away from body when spraying
- For children under 6 months of age, ask a doctor
- Do not spray directly on face and avoid breathing mist
- Spray on hand and apply to face. Use in well-ventilated areas
- Sun Protection Measures: Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses
- Reapply:
- • after 80 minutes of swimming or sweating
- • immediately after towel use
- • at least every 2 hours
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Glyceryl Caprylate, Glycerin, Caprylic/Capric Triglycerides, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Coco-Caprylate, Fragrance, Glyceryl Oleate Citrate, Methylheptyl Isostearate, Pentylene Glycol, Polyhydroxystearic Acid, Sodium Chloride, Sorbitan Oleate, Tocopheryl Acetate, Water
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