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  5. Label Information: Sunscreen

FDA Label for Sunscreen

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - STOP USE
    8. WHEN USING THIS PRODUCT
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Safetec Of America, 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.

Other



Drug Facts


Active Ingredient



Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)


Purpose



Sunscreens


Uses



  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn

Warnings



Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.


Otc - Do Not Use



Do not use on damaged or broken skin.


Otc - Stop Use



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 swallowed, get medical help or contact a poison control center right away


Directions



  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every two hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun

Inactive Ingredients



cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL – 25 count box

NDC 61010-6103-1

Safetec

Sunscreen
Lotion
SPF 30

PABA Free

25 Packets

3.5 g (1/8 oz.)

Reorder no. 53700

PRINCIPAL DISPLAY PANEL – packet

Safetec

Sunscreen
Lotion
SPF 30•PABA Free
3.5g (1/8 oz.)

Safetec of America, Inc.
Buffalo, NY 14215 800-456-7077
www.safetec.com


* Please review the disclaimer below.