SUNSHIELD SPF-30- octinoxate, octisalate, zinc oxide cream 
CONTROL CORRECTIVE SKINCARE INC

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 6.9%, OCTISALATE 3%, ZINC OXIDE 4%

USES:

HELPS PREVEN SUNBURN

WARNINGS:

SKIN CANCER/SKIN AGING ALERT: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING SKIN. THIS PRODUCT HAS BEEN SLOWN ONLY TO PREVEN SUNBURN, NOT SKIN CANCER OR EALY SKIN AGING.

  • FOR EXTERNAL USE ONLY.
  • DO NOT USE ON DAMAGED OR BROKEN SKIN.
  • WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
  • REAPPLY EVERY 40 MINUTES.
  • STOP USE AND ASK 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.

INACTIVE INGREDIENTS:

WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOMETHICONE, CETEARYL ALCOHOL, CETEARETH-2, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, VP/EICOSENE COPOLYMER, SQUALANE, BUTYROSPERMUM PARKII (SHEA) BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, IMIDAZOLIDINYL UREA, METHYLPARABEN, TOCOPHERYL ACETATE, POLYSORBATE 60, FRAGRANCE, DISODIUM EDTA, PROPYLPARABEN, TRIETHOXYCAPRYLYLSYLANE, RETINYL PALMITATE, CITRIC ACID.

Sunshield Broad Spectrum SPF-30_UC.jpg

SUNSHIELD  SPF-30
octinoxate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70764-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 (UNII: NMQ347994Z)  
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)  
SHEA BUTTER (UNII: K49155WL9Y)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70764-202-541 in 1 BOX08/04/2016
1NDC:70764-202-14120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/04/201611/17/2018
Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)
Establishment
NameAddressID/FEIBusiness Operations
Chemolee Lab Corporation809982754manufacture(70764-202)

Revised: 11/2018
Document Id: 89e960a8-9ce4-4cc7-bcdd-41b722eea44b
Set id: 6afad6ee-d71c-4147-99cf-a482e0811d2d
Version: 3
Effective Time: 20181117
 
CONTROL CORRECTIVE SKINCARE INC