JOHNSONS BABY MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide (6.5%), Zinc Oxide (18.7%)

Purpose

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 and evenly 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
• Do not use if quality seal is broken or missing.

Inactive ingredients

Water, Isohexadecane, C12-15 Alkyl Benzoate, Ethylhexyl methoxycrylene, Behenyl Alcohol, Steareth-21, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Glyceryl Stearate, Ethylhexylglycerin, Xanthan Gum, Calcium Sodium Borosilicate, Aluminum Hydroxide, Triethoxycaprylylsilane, Cetyl Alcohol, Stearic Acid, Polyhydroxystearic Acid, Disodium EDTA, PEG-100 Stearate, Chlorphenesin, Phenoxyethanol

Questions or comments?

866-565-BABY; Outside US, dial collect 215-273-8755.

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC

Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

clinically tested

safe for babies

new

Johnson’s ®

baby

SPF

30

no

more

tears ®

mineral

sunscreen

lotion

with aloe & vitamin E

for baby’s delicate skin

broad spectrum SPF 30

water resistant (80 minutes)

3.0 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

JOHNSONS BABY MINERAL SUNSCREEN SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-1001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
PEG-100 STEARATE (UNII: YD01N1999R)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ISOHEXADECANE (UNII: 918X1OUF1E)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-1001-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	04/29/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/29/2026

Labeler - Kenvue Brands LLC (118772437)