AVEENO POSITIVELY MINERAL SENSITIVE SKIN FACE MILK SUNSCREEN BROAD SPECTRUM SPF 40 PLUS- titanium dioxide and zinc oxide lotion

Aveeno Positively Mineral Sensitive Skin Face Milk Sunscreen Broad Spectrum SPF 40 Plus by

Drug Labeling and Warnings

Aveeno Positively Mineral Sensitive Skin Face Milk Sunscreen Broad Spectrum SPF 40 Plus 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 INGREDIENT

Active ingredients	Purpose
Titanium Dioxide (4.9%)	Sunscreen
Zinc Oxide (2.9%)	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 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, Trisiloxane, Styrene/Acrylates Copolymer, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, PPG-12/SMDI Copolymer, Bisabolol, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Magnesium Sulfate, DMDM Hydantoin, Triethoxycaprylylsilane, BHT

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 - 40 mL Bottle Label

Aveeno®
POSITIVELY
MINERAL™
sensitive skin

face milk
sunscreen

BROAD SPECTRUM
SPF 40+
1.4 fl oz (40 mL)

INGREDIENTS AND APPEARANCE

AVEENO POSITIVELY MINERAL SENSITIVE SKIN FACE MILK SUNSCREEN BROAD SPECTRUM SPF 40 PLUS 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0581
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	49 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Dimethicone (UNII: 92RU3N3Y1O)
Trisiloxane (UNII: 9G1ZW13R0G)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)
LEVOMENOL (UNII: 24WE03BX2T)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Caprylyl Glycol (UNII: 00YIU5438U)
Stearic Acid (UNII: 4ELV7Z65AP)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DMDM Hydantoin (UNII: BYR0546TOW)
Triethoxycaprylylsilane (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0581-1	40 mL in 1 BOTTLE; 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)