OTC Medication Information: Aveeno Positively Mineral Sensitive Skin Sunscreen For Face Broad Spectrum SPF 50

AVEENO POSITIVELY MINERAL SENSITIVE SKIN SUNSCREEN FOR FACE BROAD SPECTRUM SPF 50- zinc oxide lotion
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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, Tocopheryl Acetate

Questions

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

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

PRINCIPAL DISPLAY PANEL — 59 mL Tube Carton

DERMATOLOGIST
RECOMMENDED

Aveeno ®
POSITIVELY
MINERAL™
sensitive skin
sunscreen
BROAD SPECTURM SPF 50
FOR FACE

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

50

2.0 fl. oz (59 mL)

PRINCIPAL DISPLAY PANEL -- 59 mL Tube Carton
(click image for full-size original)
AVEENO POSITIVELY MINERAL SENSITIVE SKIN SUNSCREEN FOR FACE BROAD SPECTRUM SPF 50
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0394
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 216 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALKYL (C12-15) BENZOATE
DIMETHICONE
GLYCERIN
PHENOXYETHANOL
PHENYL TRIMETHICONE
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER
OCTYLDODECYL CITRATE CROSSPOLYMER
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
POLYHYDROXYSTEARIC ACID (2300 MW)
SILICON DIOXIDE
ETHYL METHICONE (8 MPA.S)
CETYL DIMETHICONE 25
TRIETHOXYCAPRYLYLSILANE
GLYCERYL DIBEHENATE
SODIUM CHLORIDE
CHLORPHENESIN
PHENYLETHYL ALCOHOL
OATMEAL
CAPRYLYL GLYCOL
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER
FEVERFEW
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0394-2 59 mL in 1 TUBE None
2 NDC:69968-0394-3 1 TUBE in 1 CARTON contains a TUBE
2 59 mL in 1 TUBE This package is contained within the CARTON (69968-0394-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2018 12/17/2024
Labeler — Johnson & Johnson Consumer Inc. (118772437)

Revised: 02/2023 Johnson & Johnson Consumer Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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