SUN SAVVY SOLAR SHIELD SPF 20

SUN SAVVY SOLAR SHIELD SPF 20- zinc oxide titanium dioxide lotion
APPLIED SKIN TECHNOLOGY LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS:
ZINC OXIDE 5% TITANIUM DIOXIDE 5%

PURPOSE:
SUNSCREEN

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

WARNING: FOR EXTERNAL USE ONLY.

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

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

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 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 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.

DERMAGENICS
PHYSICIAN FORMULATED

SUN SAVVY
SOLAR SHIELD

FACIAL SUNSCREEN
WITH REVERSE EMULSION
TECHNOLOGY

PHYSICAL BARRIER
95% UVA/UVB
PROTECTION

SPF 20
4 FL OZ

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - APPLIED SKIN TECHNOLOGY LLC (036766984)

Registrant - CRC (Cosmoceutical Research Center) (160019006)

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