AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF50- zinc oxide lotion

Aveeno Baby continuous protection sensitive skin by

Drug Labeling and Warnings

Aveeno Baby continuous protection sensitive skin by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Zinc Oxide 21.6%

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 liberally 15 minutes before sun exposure
• 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 value of SPF 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, C 12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Polyhydroxystearic Acid, Glycerin, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Avena Sativa (Oat) Kernel Flour, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew)Flower/Leaf/Stem Juice

Questions

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

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

PRINCIPAL DISPLAY PANEL - 207 mL Tube Label

PEDIATRICIAN
RECOMMENDED BRAND
Aveeno
Baby®
CONTINUOUS
PROTECTION®
sensitive skin
zinc oxide
sunscreen
BROAD SPECTRUM SPF 50
naturally-sourced 100%
mineral active ingredient
sweat + water resistant
(80 min)
SPF
50
7.0 fl oz (mL)

INGREDIENTS AND APPEARANCE

AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN   SUNSCREEN BROAD SPECTRUM SPF50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	216 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
Dimethicone (UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Glycerin (UNII: PDC6A3C0OX)
Ethyl Methicone (8 Mpa.S) (UNII: 3YWG8XYT8H)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
Phenylethyl Alcohol (UNII: ML9LGA7468)
Oatmeal (UNII: 8PI54V663Y)
Caprylyl Glycol (UNII: 00YIU5438U)
Glyceryl Dibehenate (UNII: R8WTH25YS2)
Sodium Chloride (UNII: 451W47IQ8X)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
FEVERFEW (UNII: Z64FK7P217)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0304-1	14 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2016
2	NDC: 69968-0304-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2016
3	NDC: 69968-0304-6	2 in 1 TRAY	11/20/2019
3	NDC: 69968-0304-3	88 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 69968-0304-7	207 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2016

Labeler - Johnson & Johnson Consumer Inc. (002347102)