Drug Facts
Drug Facts
Youare Sunshine Broad Spectrum Spf 50 Mineral Sunscreen Lotion
FDA Label NDC 35192-100
14 label sections · Submitted to the FDA by Ca-botana International · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ca-botana International for the product Youare Sunshine Broad Spectrum Spf 50 Mineral Sunscreen (NDC 35192-100). 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, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Otc - Purpose
| Active Ingredient | Purpose |
| Zinc Oxide 21% | Sunscreen |
Uses
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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product
- Keep out of eyes. Rinse with water to remove
Otc - Stop Use
Stop use and ask a doctor if
- Rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours.
- Sun Protection Measures. Spending time int he 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.
- children under 6 months of age: ask a doctor
Other Safety Information
Other Information
- Protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive Ingredients
Water/Aqua/Eau, Coco-Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Glyceryl Stearate, Cetearyl Olivate, Carthamus Tinctorious (Safflower) Seed Oil, Sorbitan Olivate, Caprylhydrozamic Acid, Xanthan Gum, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (Rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Glyceryl Caprylate, Glycerin, Aesculus Hippocastanum (Horse Chestnut) Extract, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Extract, Tocopheryl Acetate, Potassium Sorbate, Sodium Phytate, Silica, Triethoxycaprylsilane, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Citric Acid, Iron Oxides (CI 77491).
Questions Or Comments?
Questions or comments? clearstem.com
Youare Sunshine Broad Spectrum Spf 50+ - 65 G - Carton
CLEARSTEM
CLEAR PORE PROMISE
YOU ARE
SUNSHINE
Broad Spectrum SPF 50+
Mineral Sunscreen
No Pore-Clogging
Ingredients, Ever
WATER RESISTANT
(80 MINUTES)
ZINC OXIDE 21%
65 g 2.2 oz
Yas (Yas)
* Please review the disclaimer below.
