SUN SAVVY SOLAR SHIELD SPF 20- zinc oxide titanium dioxide lotion

SUN SAVVY SOLAR SHIELD by

Drug Labeling and Warnings

SUN SAVVY SOLAR SHIELD by is a Otc medication manufactured, distributed, or labeled by APPLIED SKIN TECHNOLOGY LLC, CRC (Cosmoceutical Research Center). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:
ZINC OXIDE 5% TITANIUM DIOXIDE 5%

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.

WHEN USING

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

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.

PRINCIPAL DISPLAY PANEL

DERMAGENICS
PHYSICIAN FORMULATED

SUN SAVVY
SOLAR SHIELD

FACIAL SUNSCREEN
WITH REVERSE EMULSION
TECHNOLOGY

PHYSICAL BARRIER
95% UVA/UVB
PROTECTION

SPF 20
4 FL OZ

INGREDIENTS AND APPEARANCE

SUN SAVVY SOLAR SHIELD  SPF 20
zinc oxide titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55071-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOHEXADECANE (UNII: 918X1OUF1E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55071-001-04	118 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/26/2011

Labeler - APPLIED SKIN TECHNOLOGY LLC (036766984)

Registrant - CRC (Cosmoceutical Research Center) (160019006)

Establishment
Name	Address	ID/FEI	Business Operations
CRC (Cosmoceutical Research Center)		160019006	manufacture