FDA Label for Big Cloud Defend Hybrid Formula With Zinc
View Indications, Usage & Precautions
Big Cloud Defend Hybrid Formula With Zinc Product Label
The following document was submitted to the FDA by the labeler of this product Bell International Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Homosalate 2.9%, Octisalate 4.9%, Octocrylene 7.6%, Zinc Oxide 5.3%
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 damaged or broken skin
when using this product keep out of eyes. Rinse with water to remove
Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 oF.
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
Apply liberally and spread evenly by hand 15 minutes before sun exposure.
hold container 4 to 6 inches from the skin to apply.
do not spray directly onto face. Spray onto hands then apply to face
do not apply in windy conditions. Use in a well-ventilated area.
Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and 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 wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm. Wear logn-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months of age: Ask a doctor
Other Information
Protect this product from excessive heat and direct sun.
May stain or damage some fabrics or surfaces
Avoid long-term storage above 104 oF
Inactive Ingredients
water, butyloctyl salicylate, methyl dihydroabietate, coconut alkanes, potassium cetyl phosphate, propanediol, microcrystalline cellulose, caprylyl glycol, fragrance, rubus ideaus (raspberry) seed oil, oryza sativa (rice) bran extract, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, terminalia ferdinandiana fruit extract, rosmarinus officinalis (rosemary) leaf extract, opuntia vulgaris extract, helianthus annuus (sunflower) extract, tocopherol, cetearyl alcohol, glycerin, cetyl palmitate, sorbitan palmitate, triethoxycaprylylsilane, ethyl ferulate, sodium gluconate, bisabolol, cellulose gum, caprylylhydroxamic acid, sorbitan oleate, xanthan gum, coco-caprylate/caprate, sodium benzoate, potassium sorbate, citric acid, phenoxyethanol, Alpha-Isomethyl Ionone, Coumerin, Hydroxyitronellal, Linalool
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