AVEENO BABY CONTINUOUS PROTECTION SUNSCREEN BROAD SPECTRUM SPF55- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Aveeno Baby Continuous Protection by

Drug Labeling and Warnings

Aveeno Baby Continuous Protection by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (10%), (Octisalate (5%), Octocrylene (2.8%), Oxybenzone (6%)

Purpose

Sunscreen

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• apply generously 15 minutes before sun exposure
• reapply: - after 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

Other Information

• protect this product from excessive heat and direct sun
• may stain some fabrics

Inactive ingredients

Water, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Silica, Diethylhexyl 2,6-Naphthalate,VP/Hexadecene Copolymer, ,Dimethicone, Phenoxyethanol, ,Avena Sativa (Oat) Kernel Flour,Ethylhexylglycerin, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Trimethylsiloxysilicate,Sodium Polyacrylate, Ethylhexyl Stearate, Methylparaben, Behenyl Alcohol, Xanthan Gum,Propylparaben, Ethylparaben, Disodium EDTA, BHT, Trideceth-6

Questions?

1- 866-4AVEENO; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

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Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 112 g Tube Label

Aveeno®
Baby®

continuous
protection®
lotion
sunscreen

BROAD
SPECTRUM
SPF 55

mild as water
fragrance free
with soothing oatmeal
sweat + water
resistant (80 min)

55

PEDIATRICIAN
RECOMMENDED

NET WT. 4 OZ. (112 g)

INGREDIENTS AND APPEARANCE

AVEENO BABY CONTINUOUS PROTECTION   SUNSCREEN BROAD SPECTRUM SPF55
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0626
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	28 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Diethylhexyl 2,6-naphthalate (UNII: I0DQJ7YGXM)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Oatmeal (UNII: 8PI54V663Y)
Ethylhexylglycerin (UNII: 147D247K3P)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
Methylparaben (UNII: A2I8C7HI9T)
Docosanol (UNII: 9G1OE216XY)
Xanthan Gum (UNII: TTV12P4NEE)
Propylparaben (UNII: Z8IX2SC1OH)
Ethylparaben (UNII: 14255EXE39)
Edetate Disodium (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Trideceth-6 (UNII: 3T5PCR2H0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-0626-1	112 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2007

Labeler - Johnson & Johnson Consumer Inc. (002347102)