DAILY DEFLECTOR MOISTURIZER by KATE SOMERVILLE SKINCARE, LLC / Cosmetic Enterprises Ltd

Drug Details [pdf]

DAILY DEFLECTOR MOISTURIZER SPF 20- octinoxate, avobenzone, oxybenzone lotion
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

OCTINOXATE- 7.5%

AVOBENZONE- 3%

OXYBENZONE- 4%

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, AQUALANE, GLYCERIN, DIMETHICONE, NEOPENTYL GLYCOL, DIHEPTANOATE, ADIPIC ACID/DIGLYCOL ZOCROSSPOLYMER, STEARYL ALCOHOL, CETYL ALCOHOL, PROPLYENE GLYCOL DIBENZOATE, CAPRYLYL GLYCOL, BUTYLENE GLYCOL, GLYCERYL STEARATE, CYCLOPENTASILOXANE, STEARETH-21, PEG-100 STEARATE, DIETHYLHEXYL SYRINGYLIDENE MALONATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM PCA, UREA, CYCLOTETRASILOXANE, HYDROLYZED CORN STARCH, BETA VULGARIS (BEET) ROOT EXTRACT, CAPRYLHYDROXAMIC ACID, DIMETHICONOL, TREHALOSE, SILICA, HYDROXYPROPYLTRIMONIUM, MALTODEXTRIN CROSSPOLYMER, ETHYLHEXYL COCOATE, LENTINUS EDODES EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CARBOMER, POLYSORBATE 20, CUCUMIS MELO FRUIT EXTRACT, PHENYL TRIMETHICONE, POLYQUATERNIUM-51, SODIUM HYALURONATE, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, LECITHIN, GLYCOLIPIDS, SODIUM HYDROXIDE, MICA, FRAGRANCE (PARFUM), CITRONELLOL, GERANIOL, HEXYL CINNAMAL, LIMONENE, LINALOOL, TITANIUM DIOXIDE (CI 77891)

DailyDeflectorCarton_122111OL

DAILY DEFLECTOR MOISTURIZER SPF 20
octinoxate, avobenzone, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43479-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL (UNII: QI80HXD6S5)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ADIPIC ACID (UNII: 76A0JE0FKJ)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARETH-21 (UNII: 53J3F32P58)
PEG-100 STEARATE (UNII: YD01N1999R)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
UREA (UNII: 8W8T17847W)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
STARCH, CORN (UNII: O8232NY3SJ)
BEET (UNII: N487KM8COK)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
TREHALOSE (UNII: B8WCK70T7I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIHYDROXYPROPYLTRIMONIUM (UNII: 925G44QFFO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ETHYLHEXYL COCOATE (UNII: I1MPW273QS)
LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MUSKMELON (UNII: ZV095H5633)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
GLYCOLIDE (UNII: YRZ676PGU6)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MICA (UNII: V8A1AW0880)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43479-203-52	1 in 1 BOX	06/22/2014	11/18/2018
1	NDC: 43479-203-12	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/22/2014	01/21/2020

Labeler - KATE SOMERVILLE SKINCARE, LLC (615155533)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Enterprises Ltd		017701475	manufacture(43479-203)

Revised: 1/2020

Document Id: 38da2021-42f6-40cc-9816-9a86bcaab8bb

Set id: 0b9639fe-5e8c-4882-bd74-eb360d24f4e3

Version: 5

Effective Time: 20200121

KATE SOMERVILLE SKINCARE, LLC