AVEENO PROTECT PLUS SOOTHE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

Aveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Aveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 30 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 (6.5%)	Sunscreen
Zinc Oxide (18.7%)	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, Isohexadecane, C12-15 Alkyl Benzoate, Ethylhexyl methoxycrylene, Behenyl Alcohol, Steareth-21, Glyceryl Stearate, PEG-100 Stearate, Calcium Sodium Borosilicate, Euphorbia Cerifera (Candelilla) Wax, Polyhydroxystearic Acid, Cetyl Alcohol, Triethoxycaprylylsilane, Aluminum Hydroxide, Xanthan Gum, Stearic Acid, Phenoxyethanol, Ethylhexylglycerin, Glycerin, Chlorphenesin, Tocopheryl Acetate, Disodium EDTA, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Extract

Questions?

866-428-3366;

Outside US, dial collect 215-273-8755 www.aveeno.com

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Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Aveeno®

DERMATOLOGIST RECOMMENDED BRAND

SOOTHING OAT

Protect +

Soothe

MINERAL

SUNSCREEN

Broad Spectrum SPF 30

SENSITIVE SKIN

Naturally-sourced

100% mineral actives

Water resistant (80 minutes)

SPF

30

3.0 fl. OZ (88 mL)

INGREDIENTS AND APPEARANCE

AVEENO PROTECT PLUS SOOTHE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0771
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	187 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARIC ACID (UNII: 4ELV7Z65AP)
CANDELILLA WAX (UNII: WL0328HX19)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
DOCOSANOL (UNII: 9G1OE216XY)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOHEXADECANE (UNII: 918X1OUF1E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PEG-100 STEARATE (UNII: YD01N1999R)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
OAT (UNII: Z6J799EAJK)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0771-1	12 in 1 PACKAGE	10/04/2022
1		14 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69968-0771-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/04/2022

Labeler - Johnson & Johnson Consumer Inc. (118772437)