AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN SUNSCREEN FACE BROAD SPECTRUM SPF50- titanium dioxide and zinc oxide stick

Aveeno Baby continuous Protection sensitive skin sunscreen Face Broad Spectrum SPF50 by

Drug Labeling and Warnings

Aveeno Baby continuous Protection sensitive skin sunscreen Face Broad Spectrum SPF50 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

Titanium Dioxide (8.1%), Zinc Oxide (6.8%)

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 and evenly 15 minutes before sun exposure
• ensure complete coverage to the area above the lip, nose, and tops of ears.
• 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

Other information

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

Inactive ingredients

C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Dimethicone, Paraffin, Ozokerite, Beeswax, Phenyl Trimethicone, Euphorbia Cerifera (Candelilla) Wax, Polyethylene, Polyhydroxystearic Acid, Dipropylene Glycol Dibenzoate, Triethoxycaprylylsilane, PPG-15 Stearyl Ether Benzoate, Caprylyl Glycol, Ethylhexylglycerin, Avena Sativa (Oat) Kernel Flour, BHT

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 14 g Cylinder Blister Pack

PEDIATRICIAN RECOMMENDED BRAND
Aveeno
Baby®

CONTINUOUS
PROTECTION®
sensitive skin
sunscreen
face stick
BROAD SPECTRUM
SPF 50
naturally-sourced
100%
mineral active
ingredients
great for on-the-go
sweat + water
resistant (80 min)
SPF
50

net wt. 0.5 oz (14 g)

INGREDIENTS AND APPEARANCE

AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN SUNSCREEN FACE BROAD SPECTRUM SPF50 
titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0447
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	81 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	68 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Dimethicone (UNII: 92RU3N3Y1O)
Paraffin (UNII: I9O0E3H2ZE)
Yellow Wax (UNII: 2ZA36H0S2V)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Candelilla Wax (UNII: WL0328HX19)
High Density Polyethylene (UNII: UG00KM4WR7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Dipropylene Glycol Dibenzoate (UNII: 6OA5ZDY41O)
Triethoxycaprylylsilane (UNII: LDC331P08E)
PPG-15 Stearyl Ether Benzoate (UNII: 80D2J6361M)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Oat (UNII: Z6J799EAJK)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0447-1	1 in 1 BLISTER PACK	09/01/2013
1		14 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2013

Labeler - Johnson & Johnson Consumer Inc. (002347102)