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  5. Label Information: Sun-kissed Suncream

FDA Label for Sun-kissed Suncream

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. INACTIVE INGREDIENT
    8. OTHER SAFETY INFORMATION
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun-kissed Suncream Product Label

The following document was submitted to the FDA by the labeler of this product Lee & Gen Global Corporation. 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.

Otc - Active Ingredient



OCTINOXATE 7.5%
OCTISALATE 3.0%
ZINC OXIDE 8.0%


Otc - Purpose



Sunscreen


Indications & Usage



Helps prevent sunburn


Dosage & Administration



For sunscreen use:
■ 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 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


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 using and ask a doctor if rash occurs.


Otc - Keep Out Of Reach Of Children



Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.


Inactive Ingredient



Water, Cyclopentasiloxane, Ethylhexyl Isononanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Phenoxyethanol, Sodium Chloride, Triethoxycaprylylsilane, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Iodopropynyl Butylcarbamate, Ascorbyl Palmitate, BHT, Retinyl Palmitate, Dipropylene Glycol, Zea Mays (Corn) Oil, Tocopherol


Other Safety Information



Protect the product in this container from excessive heat and direct sunlight


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