AVEENO PROTECT PLUS SOOTHE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide stick

Aveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Aveeno Protect Plus Soothe Mineral 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 INGREDIENT

Active ingredients	Purpose
Zinc Oxide (21.6%)	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 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
• package contains small parts, which could cause a choking hazard

Inactive ingredients

Octyldodecyl Neopentonate,C12-15 Alkyl Benzoate, Synthetic wax, Paraffin ,Silica, Neopentyl glycol, Diethylhexonate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer ,Trihexocarpylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil, Tocopheryl Acetate

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 42g Canister Label

New!

Aveeno®

Protect +

Soothe

MINERAL

SUNSCREEN STICK

Broad Spectrum SPF 50

SENSITIVE SKIN

Water resistant (80 min)

SPF

50

net wt.1.5 OZ

(42 g)

INGREDIENTS AND APPEARANCE

AVEENO PROTECT PLUS SOOTHE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0780
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PARAFFIN (UNII: I9O0E3H2ZE)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CERESIN (UNII: Q1LS2UJO3A)
OAT KERNEL OIL (UNII: 3UVP41R77R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0780-2	42 g in 1 CANISTER; Type 0: Not a Combination Product	11/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/29/2022

Labeler - Johnson & Johnson Consumer Inc. (118772437)