NEUTROGENA MINERAL BEACH DEFENSE ACTIVE PERFORMANCE SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

Neutrogena Mineral Beach Defense Active Performance Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Neutrogena Mineral Beach Defense Active Performance 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%), 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 Aluminum Borosilicate, Euphorbia Cerifera (Candelilla) Wax, Polyhydroxystearic Acid, Cetyl Alcohol, Triethoxycaprylylsilane, Aluminum Hydroxide, Xanthan Gum, Stearic Acid, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, Tocopheryl Acetate, Disodium EDTA, Fragrance, Glycerin, Aloe Barbadensis Leaf Extract

Questions?

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

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Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 88 mL Tube

NEW

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

PURESCREEN+ TM

MINERAL

BEACH

DEFENSE ®

ACTIVE PERFORMANCE

BODY LOTION

30

SUNSCREEN

BROAD SPECTRUM SPF 30

UVA/UVB PROTECTION

100% mineral actives + aloe

water + sun ● water resistant (80 minutes)

3.0 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA MINERAL BEACH DEFENSE ACTIVE PERFORMANCE SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0773
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
GLYCERIN (UNII: PDC6A3C0OX)
DOCOSANOL (UNII: 9G1OE216XY)
STEARETH-21 (UNII: 53J3F32P58)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CANDELILLA WAX (UNII: WL0328HX19)
CETYL ALCOHOL (UNII: 936JST6JCN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0773-3	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 not final	part352	10/04/2022

Labeler - Johnson & Johnson Consumer Inc. (118772437)