Daily Deflector Waterlight by KATE SOMERVILLE SKINCARE LLC / Cosmetic Enterprises Ltd

Daily Deflector Waterlight by

Drug Labeling and Warnings

Daily Deflector Waterlight by is a Otc medication manufactured, distributed, or labeled by KATE SOMERVILLE SKINCARE LLC, Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAILY DEFLECTOR WATERLIGHT SPF 50- titanium dioxide, zinc oxide liquid 
KATE SOMERVILLE SKINCARE 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

TITANIUM DIOXIDE- 8.3%

ZINC OXIDE- 12.6%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN.
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGED OR BROKEN SKIN.

WHEN USING THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

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

• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
• REAPPLY AT LEAST EVERY 2 HOURS.
• CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

• 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 VALUE OF 15 OR HIGHER AND OTHER 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.

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
• YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PST.

INACTIVE INGREDIENTS

WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, COCO-CAPRYLATE/CAPRATE, GLYCERIN, CAPRYLYL METHICONE, DICAPRYLYL ETHER, NYLON-6/12, DICAPRYLYL CARBONATE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, COCONUT ALKANES, METHYLCELLULOSE, STEARIC ACID, POLYHYDROXYSTEARIC ACID, SODIUM HYALURONATE, TOCOPHERYL ACETATE, ADENOSINE, LENTINUS EDODES EXTRACT, TREHALOSE, TRACETIN, TOCOPHEROL, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, UREA, SODIUM PCA, FRAGRANCE (PARFUM), ETHYLHEXYLGLYCERIN, POLYSORBGATE 20, POLYQUATERNIUM-51, CARBOMER, PENTYLENE GLYCOL, SODIUM LACTATE, DISODIUM EDTA, BENZOIC ACID, POTASSIUM SORBATE, PHENOXYETHANOL, ALUMINA

DAILY DEFLECTOR WATERLIGHT  SPF 50
titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43479-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
NYLON-12 (UNII: 446U8J075B)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
COCONUT ALKANES (UNII: 1E5KJY107T)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADENOSINE (UNII: K72T3FS567)
LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)
TREHALOSE (UNII: B8WCK70T7I)
TRIACETIN (UNII: XHX3C3X673)
TOCOPHEROL (UNII: R0ZB2556P8)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
UREA (UNII: 8W8T17847W)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM LACTATE (UNII: TU7HW0W0QT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43479-201-52	1 in 1 BOX	06/22/2014	11/18/2018
1	NDC: 43479-201-12	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/22/2014	01/21/2020

Labeler - KATE SOMERVILLE SKINCARE LLC (615155533)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(43479-201)

Revised: 1/2020

Document Id: b5e06c9f-bba1-48ce-8de6-ca6f53b04c47

34390-5

Set id: 16d29981-d0c8-4120-b042-41bb7e2c1e29

Version: 4

Effective Time: 20200121