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Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Johnsons Baby Mineral Sunscreen Spf 30 Lotion
FDA Label NDC 69968-1001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Johnsons Baby Mineral Sunscreen Spf 30 (NDC 69968-1001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Do Not Use
Do not use on damaged or broken skin
When Using This Product
keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
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.
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)
Johnsons (Johnsons 1)
* Please review the disclaimer below.
