Active Ingredients
Titanium Dioxide - 5%
Zinc Oxide - 10%
Sand Cloud Mineral Sunscreen Lotion
FDA Label NDC 83081-2045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sand Cloud Holdings, Llc for the product Sand Cloud Mineral Sunscreen (NDC 83081-2045). 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, uses, warnings, directions, other information, inactive ingredients, questions?, sand cloud mineral sunscreen 3oz, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Helps prevent sunburn
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 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 prior to use
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: 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 the sun especially from 10 a.m.- 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- reapply :
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
Other Information
- protect the product in this container from excessive heat and direct sun
- may stain some fabrics
Inactive Ingredients
Alumina, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer
Questions?
Call 619-693-8397 or visit www.sandcloud.com
Sand Cloud Mineral Sunscreen 3Oz
SAND CLOUD
MINERAL SUNSCREEN
SPF 30
BROAD SPECTRUM SPF 30
WATER RESISTANT
(40 MINUTES)
FRAGRANCE FREE
* Please review the disclaimer below.
