AVEENO POSITIVELY MINERAL SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

Aveeno Positively Mineral Sensitive Skin Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Aveeno Positively Mineral Sensitive Skin Sunscreen Broad Spectrum SPF 50 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 ingredients

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 generously and evenly 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 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, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Styrene/Acrylates copolymer, Octyl dodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic acid, Silica, Ethyl methicone,Cetyl Dimethicone, Triethoxycaprylylsilane, 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?

886-428-3366; 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 - 88 mL Tube Label

DERMATOLOGIST
 RECOMMENDED

Aveeno®
POSITIVELY
MINERAL™

sensitive skin
sunscreen

BROAD SPECTRUM SPF 50

naturally-sourced
100% zinc oxide
active ingredient
sweat + water resistant
(80 min)

SPF

50

3.0 fl. oz (88 mL)

INGREDIENTS AND APPEARANCE

AVEENO POSITIVELY MINERAL SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0395
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)
Dimethicone (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Glycerin (UNII: PDC6A3C0OX)
Phenoxyethanol (UNII: HIE492ZZ3T)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Ethyl Methicone (8 Mpa.S) (UNII: 3YWG8XYT8H)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Glyceryl Dibehenate (UNII: R8WTH25YS2)
Sodium Chloride (UNII: 451W47IQ8X)
Chlorphenesin (UNII: I670DAL4SZ)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
OATMEAL (UNII: 8PI54V663Y)
Caprylyl Glycol (UNII: 00YIU5438U)
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)
FEVERFEW (UNII: Z64FK7P217)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0395-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 69968-0395-1	14 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)