Otc - Active Ingredient
Active Ingredients
Avobenzone 2.70%
Homosalate 9.50%
Octisalate 4.50%
Holika Holika Aloe Cica Uv Defense Sunscreen Cream
FDA Label NDC 69551-151
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Enprani Co., Ltd. for the product Holika Holika Aloe Cica Uv Defense Sunscreen (NDC 69551-151). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
SUNSCREEN
Indications & Usage
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
Warnings
■
For external use only
■
Do not use on damaged or broken skin
■
Stop use and ask a doctor if rash occurs
■
When using this product, keep out of eyes. rinse with water to remove
■
Keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away
Dosage & Administration
Directions
■ Apply liberally 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 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 of 15 or higher and other sun protection measures including: ■ limited time in the sun, especially from 10 am to 2 pm. ■ wear long-sleeve 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, Butyloctyl Salicylate, Propanediol, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Hydrogenated Soy Polyglycerides, Polymethylsilsesquioxane, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Centella Asiatica Root Extract, Pentylene Glycol, Sodium Acrylates Crosspolymer-2, Polyglyceryl-3 Distearate, Potassium Cetyl Phosphate, Cetearyl Olivate, Butylene Glycol, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, C15-23 Alkane, VP/Eicosene Copolymer, Tromethamine, Glyceryl Stearate Citrate, Cetearyl Alcohol, Carbomer, Xanthan Gum, Fragrance(Parfum)
Otc - Questions
Questions?
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