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Sunscreen

Safetec of America, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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 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

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

Sunscreen

Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61010-6103
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 6 mg
OCTINOXATE OCTINOXATE 7.5 mg
OCTISALATE OCTISALATE 5 mg
OXYBENZONE OXYBENZONE 5 mg

Inactive Ingredients

Ingredient Name Strength
CETYL ALCOHOL
POVIDONE K30
propylene glycol
PROPYLPARABEN
METHYLPARABEN
DIAZOLIDINYL UREA
POLYOXYL 40 STEARATE
POLYSORBATE 60
petrolatum
water
SORBITAN MONOSTEARATE
EDETATE SODIUM
titanium dioxide
XANTHAN GUM
polyethylene glycol 400
DIMETHICONE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61010-6103-0 3.5 in 1 PACKET
2 NDC:61010-6103-1 25 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2007-03-13


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