Otc - Active Ingredient
Zinc Oxide 24.1%
Sun Kids Mineral Blueberry Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 87138-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Natural Skn Company for the product Sun Kids Mineral Blueberry Sunscreen Broad Spectrum Spf 50 (NDC 87138-002). 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 otc - active ingredient, warnings, uses, otc - do not use, directions, inactive ingredient, storage and handling, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
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 a doctor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.
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
Otc - Do Not Use
Do not use on damaged or broken skin.
Directions
Directions
. apply liberally and evenly 15 minutes before sun exposure
reapply:
. after 40 minutes of swimming or sweating
. at least every 2 hours
. 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.
ยท wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Other Ingredients:
Water (Aqua)
C12-15 Alkyl Benzoate
Caprylic/Capric Triglyceride
C13-15 Alkane
Glycerin
Polyglyceryl-6 Polyricinoleate
Coconut Alkanes
Silica
Isododecane
Triheptanoin
Sodium Chloride
Squalane (Olive derived)
Fragrance
Terminalia Ferdinandiana Fruit Extract
Vaccinium Myrtillus (Blueberry) Fruit Extract
Coco-Caprylate/Caprate
Polyglyceryl-10 Dioleate
Disteardimonium Hectorite
Hydrogenated Phosphatidylcholine
Tocopheryl Acetate (Vitamin E)
Caprylhydroxamic Acid
Dilinoleic Acid/Butanediol Copolymer
Castor Oil/IPDI Copolymer
Glyceryl Caprylate
Polyhydroxystearic Acid
Genipa Aericana Fruit Extract
Propylene Carbonate
Saccharomyces Ferment
Lauroyl Lysine
Storage And Handling
. protect product from excessive heat and direct sun
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
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