Premium Sunscreen
FDA Label NDC 71585-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Salt And Stone for the product Premium Sunscreen (NDC 71585-105). 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 active ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

ZINC OXIDE 20%

Purpose

SUNSCREEN

Use

HELPS PREVENT SUNBURN.

Warnings

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

IF RASH OCCURS, DISCONTINUE USE AND CONSULT A HEALTH CARE PRACTITIONER.

WHEN USING THIS PRODUCT: KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

For use on children less than 6 months of age, consult a health care practitioner. Apply liberally/generously (and evenly) 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. 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 of 15 or higher and other sun protection measures, including Limit time in the sun, especially from 10am - 2pm. wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

*Aloe Barbadensis Juice, *Cera Alba (Beeswax), Cetearyl Alcohol, Citric Acid, *Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, *Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethylcellulose, Phenoxyethanol, *Simmondsia Chinesnsis (Jojoba) Oil, Sodium Citrate, Sodium Stearoyl Lactylate, Stearic Acid, *Theobroma Cacao (Cocoa) Butter, *Tocopherol (Vitamin E), *Vanilla, *Vitellaria Paradox (Shea) Butter, Xanthan Gum

*Certified Organic

Other Information

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

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