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DRUG FACTS
Attitude Sunly Baby Mineral Sunscreen Spf 50 Unscented Cream
FDA Label NDC 61649-521
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 9055-7588 Qu�bec Inc.dba Attitude for the product Attitude Sunly Baby Mineral Sunscreen Spf 50 Unscented (NDC 61649-521). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, 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
Otc - Active Ingredient
Zinc oxide (24 %)
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Warnings
For external use only.
Otc - Do Not Use
Do not use on broken skin.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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.
Otc - Stop Use
Stop use and consult a doctor if rash occurs
Other Safety Information
Allergens-Soybean (Maleated Soybean Oil Glyceryl / Octyldodecanol Esters)
Dosage & Administration
Adultds and children older than 6 months • Apply generously 15 min before sun exposure • Reapply at least every 2 h • 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 ≥ 15 and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats, and sunglasses • Use a water resistant sunscreen if swimming or sweating • Children under 6 months of age: Ask a doctor.
Inactive Ingredient
Aqua / Water / Eau, Butylene Glycol Dicaprylate/Dicaprate, Propanediol Dicaprylate/Caprate, Dicaprylyl Ether, C13-15 Alkane, Calcium Aluminum Borosilicate, Propanediol, Jojoba Esters, Mica, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyhydroxystearate, Coco-Caprylate/Caprate, Magnesium Sulfate, Maleated Soybean Oil Glyceryl / Octyldodecanol Esters (Soybean/Soja), Polyglyceryl-6 Polyricinoleate, Helianthus Annuus (Sunflower) Seed Wax, Heptyl Undecylenate, Polyhydroxystearic Acid, Glyceryl Behenate, Polyglycerin-6, Acacia Senegal Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Xanthan Gum, Sodium Benzoate, Stearalkonium Hectorite, Propylene Carbonate, Silica, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Ascorbyl Palmitate.
Storage And Handling
Store at temperatures < 90F and protect from direct sun.
Otc - Questions
Questions ? 1-855-509-7225
Package Label.Principal Display Panel
ATTITUDE
EWG Verified
VEGAN
SPF 50+
UVA ¦ UVB
NON NANO
unscented
mineral sunscreen
Broad spectrum SPF 50+
baby
sunly
85g / 3 oz. net wt.
NPN 80143422
Made in Canada
Dermatologically tested
16521-01 (16521 01)
* Please review the disclaimer below.
