Sun Savvy Solar Shield
FDA Label NDC 55071-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Applied Skin Technology Llc for the product Sun Savvy Solar Shield (NDC 55071-001). 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 - when using, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS:ZINC OXIDE 5% TITANIUM DIOXIDE 5%

Otc - Purpose

PURPOSE:SUNSCREEN

Indications & Usage

USES: PREVENTION OF SUNBURN, REDUCTION OF SKIN DAMAGE AND PREMATURE AGING CAUSED BY SUN EXPOSURE.

Warnings

WARNING: FOR EXTERNAL USE ONLY.

Otc - When Using

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 SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

DIRECTIONS: APPLY A SMALL AMOUNT EVENLY BEFORE SUN EXPOSURE AND AS NEEDED. ASK A DOCTOR BEFORE USE ON CHILDREN UNDER 6 MONTHS OF AGE. REAPPLY AFTER TOWEL DRYING, SWIMMING OR PERSPIRING.

Other Safety Information

OTHER INFORMATION: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL AFFECTS OF THE SUN. MAY STAIN FABRIC.

Inactive Ingredient

INACTIVE INGREDIENTS: PURIFIED WATER, CETYL DIMETHICONE COPOLYOL, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, ETHYLHEXYL PALMITATE, ISOHEXADECANE, CAPRIC CAPRYLIC TRIGLYCERIDES, DIMETHICONE, CETYL DIMETHICONE, SODIUM CHLORIDE, SODIUM PCA, PHENOXYETHANOL, ISOPENTYLDIOL, CAPRYLYL GLYCOL, ALLANTOIN.

Package Label.Principal Display Panel

DERMAGENICSPHYSICIAN FORMULATEDSUN SAVVYSOLAR SHIELDFACIAL SUNSCREENWITH REVERSE EMULSIONTECHNOLOGYPHYSICAL BARRIER95% UVA/UVBPROTECTIONSPF 204 FL OZ

* Please review the disclaimer below.