BOTANICAL SOOTHING SPF-30- octinoxate, octisalate, zinc oxide cream

BOTANICAL SOOTHING by

Drug Labeling and Warnings

BOTANICAL SOOTHING by is a Otc medication manufactured, distributed, or labeled by CONTROL CORRECTIVE SKINCARE INC, Chemolee Lab Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE (6.9%)

OCTISALATE (3.0%)

ZINC OXIDE (4.0%)

PURPOSE

SUNSCREEN

USE

A SOOTHING, CALMING AND HYDRATING MOISTURIZER IN ONE. ALSO HELPS TO REDUCE THE APPEARANCE OF SKIN FLUSHING, REDNESS AND VASCULAR STIMULATION. CONTAINING SPF 30 TO FIGHT THE SIGNES OF AGING. A MUST FOR THOSE SUFFERING WITH SKIN AND SUN SENSITIVITIES.

WARNING

FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. DISCONTINUE USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS.

DIRECTIONS

APPLY GENEROUSLY WITH FINGERS TO ENTIRE FACE AND NECK. USE DAILY.

OTHER SAFETY INFORMATION

SUN ALERT: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISK OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

INACTIVE INGREDIENTS

WATER, ALOE BARBADENSIS LEAF, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDES, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, CETEARETH-20, VP/EICOSENE COPOLYMER, SQUALANE, POLYSORBATE 60, CYCLOTETRASILOXANE, PHENOXYETHANOL, BUTYROSPERMUM PARKII BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, TOCOPHERYL ACETATE, VACCINIUM MYRTILLUS FRUIT/LEAF EXTRACT, SACCHARUM OFFICINARIUM (SUGAR CANE) EXTRACT, ACER SACCHARUM EXTRACT, CITRUS AURANTIUM DULCIS FRUIT EXTRACT, CITRUS LIMON (LEMON) FRUIT EXTRACT, CITRUS GRANDIS SEED EXTRACT, HONEY EXTRACT, CITRIC ACID, PHYTONADIONE, METHYLISOTHIAZOLINONE, RED 33.

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.

QUESTIONS OR COMMENTS

WWW.CONTROLCORRECTIVE.COM

TOLL FREE 1-866-290-4290  MADE IN USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTANICAL SOOTHING  SPF-30
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70764-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VACCINIUM MYRTILLUS WHOLE (UNII: EE76EZ4QNZ)
ACER SACCHARUM WHOLE (UNII: KEG5092LU9)
CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)
CITRUS LIMON WHOLE (UNII: EEI224A33Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CITRUS MAXIMA SEED (UNII: 083X55C543)
HONEY (UNII: Y9H1V576FH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PHYTONADIONE (UNII: A034SE7857)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70764-201-52	1 in 1 BOX	06/08/2016
1	NDC: 70764-201-22	74 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/08/2016

Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(70764-201)