Neutrogena Invisible Daily Defense Body Sunscreen Broad Spectrum SPF 60 Plus: Package Insert and Label Information

NEUTROGENA INVISIBLE DAILY DEFENSE BODY SUNSCREEN BROAD SPECTRUM SPF 60 PLUS- avobenzone, homosalate, octocrylene and octisalate spray
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 Purpose
Avobenzone 3%% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% 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.
  • keep away from face to avoid breathing it

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

Warning: FLAMMABLE. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

  • shake well before and frequently during use
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply. Rub in.
  • do not spray directly into face. Spray on hands and then apply to face. Rub in.
  • do not apply in windy conditions.
  • use in well-ventilated area
  • 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

Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice

Questions?

Call toll-free 800-299-4786 or 215-273-8755 (collect) or visit www.neutrogena.com

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

PRINCIPAL DISPLAY PANEL — 141 g Bottle Label

NEW
Neutrogena®
#1 DERMATOLOGIST RECOMMENDED BRAND
Invisible Daily
defense
body spray

sunscreen
BROAD SPECTRUM SPF 60+
60+ sun + environment
oxybenzone free
water resistant (80 minutes)
5.0 OZ (141 g)

PRINCIPAL DISPLAY PANEL -- 141 g Bottle Label
(click image for full-size original)
NEUTROGENA INVISIBLE DAILY DEFENSE BODY SUNSCREEN BROAD SPECTRUM SPF 60 PLUS
avobenzone, homosalate, octocrylene, and octisalate spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0682
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 30 mg in 1 g
Homosalate (Homosalate) Homosalate 100 mg in 1 g
Octocrylene (Octocrylene) Octocrylene 100 mg in 1 g
Octisalate (Octisalate) Octisalate 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
Isobutane
Dicaprylyl Carbonate
Polyester-7
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
Neopentyl Glycol Diheptanoate
.ALPHA.-TOCOPHEROL ACETATE
FEVERFEW
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0682-5 141 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 10/05/2020
Labeler — Johnson & Johnson Consumer Inc. (002347102)

Revised: 06/2020 Johnson & Johnson Consumer Inc.

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