Baby Sunscreen
FDA Label NDC 42263-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Seventh Generation Inc for the product Baby Sunscreen (NDC 42263-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ZINC OXIDE 20%

Otc - Purpose

SUNSCREEN

Indications & Usage

Other Information• protect the product in this container from excessive heat and direct sun

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

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 product is swallowed, get medicalhelp or contact a Poison Control Center right away.

Dosage & Administration

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

Other Safety Information

Sun Protection Measures. Spending time in the sun increases yourrisk of skin cancer and early skin aging. To decrease this risk, regularlyuse a sunscreen with a Broad Spectrum SPF value of 15 or higher andother 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

Pediatric Use

  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Inactive Ingredient

Inactive ingredients Aloe barbadensis leaf juice, anthemisnobilis flower oil, caprylic/capric triglycerides, helianthus annuus seedoil, hydrogenated methyl abietate, lavandula angustifolia flower oil,magnesium sulfate, olea europaea fruit oil, polyaminopropylbiguanide, polyglycerol-10 laurate, ricinus communis seed oil,simmondsia chinensis seed oil, sorbitan stearate, tocopherol, water.

Storage And Handling

Other Information• protect the product in this container from excessive heat and direct sun

Package Label.Principal Display Panel

SEVENTH GENERATIONFOR THE WEE GENERATIONBABY SUNSCREENBROAD SPECTRUM SPF 30

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