BULLFROG KIDS SUNSCREEN BROAD SPECTRUM SPF 50 PLUS - avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BULLFROG KIDS Sunscreen Broad Spectrum SPF 50+

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreens

Uses

helps prevent sunburn

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 use and ask a doctor if

rash occurs

Flammable

do not use near heat, flame or while smoking
avoid long term storage above 104°F (40°C)
do not puncture or incinerate. Contents under pressure.
do not store at temperatures above 120°F (49°C)

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
    * reapply:
    *
          o after 80 minutes of swimming or sweating
          o immediately after towel drying
          o at least every 2 hours

    * children under 6 months: ask a doctor

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

Inactive Ingredients

acacia farnesiana flower extract, acrylates/octylacrylamide copolymer, aloe barbadensis leaf extract, camellia oleifera leaf extract, chamomilla recutita (matricaria) flower extract, cyclomethicone, ethylhexyl palmitate, fragrance, glycerin, isopropyl myristate, lavandula angustifolia (lavender) extract, phenethyl benzoate, PPG-12/SMDI copolymer, propylene glycol, rosmarinus officinalis (rosemary) leaf extract, SD alcohol 40 (52% w/w), tocopheryl acetate (309-013)

Dist. by Chattem, Inc. © 2012
P.O. Box 2219, Chattanooga, TN 37409-0219 USA

BULLFROG KIDS Sunscreen Broad Spectrum SPF 50+ 177ml

BULLFROG KIDS SUNSCREEN BROAD SPECTRUM SPF 50 PLUS
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:41167-3319
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (AVOBENZONE)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (HOMOSALATE)	HOMOSALATE	150 mg in 1 mL
OCTISALATE (OCTISALATE)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	100 mg in 1 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
VACHELLIA FARNESIANA FLOWER
ALOE VERA LEAF
CAMELLIA OLEIFERA LEAF
CHAMOMILE
CYCLOMETHICONE
ETHYLHEXYL PALMITATE
GLYCERIN
ISOPROPYL MYRISTATE
PHENETHYL BENZOATE
PROPYLENE GLYCOL
ROSEMARY
ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE, D-

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-3319-1	177 mL in 1 CAN

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/06/2012

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
Formulated Solutions, LLC		143266687	manufacture(41167-3319)

Revised: 12/2012

Document Id: 4c885b29-3bc7-4953-8e4a-27d2edbbdb5f

Set id: 3c0aac8c-af1f-44b4-b4f4-a61bb64e0871

Version: 1

Effective Time: 20121219

Chattem, Inc.