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

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]

SPL UNCLASSIFIED SECTION

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
• 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
• package contains small parts, which could cause a choking hazard

Inactive ingredients

Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Polyethylene, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil, Tocopheryl Acetate

Questions?

Call toll-free 866-428-3366 or 215-273-8755 (collect).
www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 42 g Canister Label

Aveeno®

POSITIVELY

MINERAL™

NEW

sensitive skin

sunscreen stick

BROAD SPECTRUM

SPF 50

50

sweat + water
resistant (80min)

net wt 1.5 oz (42 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0582
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 g

Inactive Ingredients
Ingredient Name	Strength
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
High Density Polyethylene (UNII: UG00KM4WR7)
Paraffin (UNII: I9O0E3H2ZE)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
Ceresin (UNII: Q1LS2UJO3A)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Adipic Acid/Diglycol Crosspolymer (20000 MPA.S) (UNII: R9TPS68K19)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)
Caprylyl Glycol (UNII: 00YIU5438U)
Oat Kernel Oil (UNII: 3UVP41R77R)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0582-1	42 g in 1 CANISTER; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)