OTC Medication Information: Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 15

AVEENO POSITIVELY RADIANT DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate and octisalate 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 ingredient Purpose
Avobenzone 3% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 2 % Sunscreen

Use

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an 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

For sunscreen use:

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soyabean) Seed Extract, Phenyl Trimethicone, Glycerin, Arachidyl Alcohol, Cetearyl Glycoside, Phenoxyethanol, Benzyl Alcohol, Panthenol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Fragrance, Steareth-21, Polymethyl Methacrylate, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Laureth-7, Silica, Benzalkonium Chloride, Iodopropynyl Butylcarbamate, BHT, Sodium Hydroxide, Citric Acid, Titanium Dioxide, Mica

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 — 120 mL Bottle Carton

DERMATOLOGIST RECOMMENDED

Aveeno ®
POSITIVELY
RADIANT ®

daily moisturizer
sunscreen
BROAD SPECTRUM
SPF 15
clinically proven to even
skin tone and texture

TOTAL SOY COMPLEX

4.0 fl oz (120 mL)

PRINCIPAL DISPLAY PANEL -- 120 mL Bottle Carton
(click image for full-size original)
AVEENO POSITIVELY RADIANT DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0371
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALKYL (C12-15) BENZOATE
CETOSTEARYL ALCOHOL
DIMETHICONE
SOYBEAN
GLYCERIN
ARACHIDYL ALCOHOL
PHENOXYETHANOL
CETEARYL GLUCOSIDE
PANTHENOL
BENZYL ALCOHOL
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S)
DOCOSANOL
STEARETH-2
STEARETH-21
POLY(METHYL METHACRYLATE; 450000 MW)
ARACHIDYL GLUCOSIDE
EDETATE DISODIUM ANHYDROUS
C13-14 ISOPARAFFIN
SODIUM HYDROXIDE
LAURETH-7
BENZALKONIUM CHLORIDE
PHENYL TRIMETHICONE
IODOPROPYNYL BUTYLCARBAMATE
BUTYLATED HYDROXYTOLUENE
TITANIUM DIOXIDE
MICA
SILICON DIOXIDE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0371-4 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 120 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (69968-0371-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2015 02/08/2024
Labeler — Johnson & Johnson Consumer Inc. (118772437)

Revised: 05/2023 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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