CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREEN- octinoxate, octisalate, zinc oxide cream

CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING by

Drug Labeling and Warnings

CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING 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 MULTI-PURPOSE , NON-GREASY MOISTURIZER AND SUNSCREEN TO HELP REDUCE FREE RADICAL DAMAGE AND ENCOURAGE SKIN BRIGHTENING.

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

MAY BE USED TWICE DAILY WHEN APPLIED TO CLEAN, DRY SKIN.

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, KOJIC DIPALMITATE, CETEARYL ALCOHOL, CETEARETH-20, VP/EICOSENE COPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, CYCLOTETRASILOXANE, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, GLYCYRRHIZA GLABRA ROOT EXTRACT, PHENOXYETHANOL, BUTYROSPERMUM PARKII SHEA BUTTER, PERSEA GRATISSIMA OIL, FRAGRANCE, TOCOPHERYL ACETATE, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, ARBUTIN, CITRIC ACID, METHYLISOTHIAZOLINONE

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

CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING  SPF-30 SUNSCREEN
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70764-205
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)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
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)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
GLYCYRRHIZA INFLATA ROOT (UNII: 1MV1Z7MKVQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARBUTIN (UNII: C5INA23HXF)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70764-205-52	1 in 1 BOX	09/11/2018
1	NDC: 70764-205-22	74 mL in 1 TUBE; 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	09/11/2018

Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(70764-205)