TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G10- sunscreen cream
TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G20- sunscreen cream
TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G30- sunscreen cream
TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G40- sunscreen cream
TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G50- sunscreen cream
TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G60- sunscreen cream
TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G70- sunscreen cream
TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G80- sunscreen cream
Cover FX Skin Care 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.

----------

ACTIVE INGREDIENTS

Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 8.5% w/w

PURPOSE

Sunscreen

USE

Helps prevent sunburn

WARNINGS

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.

STOP USE AND ASK A DOCTOR

if rash occurs

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

DIRECTIONS

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: 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 the product in this container from excessive heat and direct sun
• Store between 15-25C

INACTIVE INGREDIENTS

Diisostearyl Malate, Polyglyceryl-2 Triisostearate, Silica, Caprylic/Capric Triglyceride, Tris(PPG-3 Benzyl Ether) Citrate, Synthetic Beeswax, Hydrogenated Polyisobutene, Triacontanyl PVP, Squalane, Neopentyl Glycol Dicaprate, Copernicia Cerifera (Carnauba) Wax/Cire de carnauba, C12-15 Alkyl Benzoate, Tocopherol, Tribehenin, Ethyl Linoleate, Ethyl Linolenate, Ethyl Oleate, Triethoxycaprylylsilane, Dehydroacetic Acid, Tetrahexyldecyl Ascorbate, Bisabolol, Phytosphingosine, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide (+/-) Titanium Dioxide, Iron Oxides, Chromium Oxide Greens

PRODUCT PACKAGING

MM1 MM1 MM1 MM1 MM1 MM1 MM1 MM1

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G10
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-061
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-061-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G20
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-062
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-062-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G30
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-063
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-063-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G40
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-064
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-064-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G50
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-065
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-065-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G60
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-066
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-066-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G70
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-067
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-067-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

TOTAL COVER CREAM FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN G80
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-068
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 2 (UNII: C04977SRJ5)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ETHYL LINOLENATE (UNII: T54Y8H042V)
ETHYL OLEATE (UNII: Z2Z439864Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TRIS(PPG-3 BENZYL ETHER) CITRATE (UNII: 52AOS9G13Q)
CHROMIC OXIDE (UNII: X5Z09SU859)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-068-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2015	09/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2015	09/30/2015

Labeler - Cover FX Skin Care Inc. (202908021)

Registrant - Cover FX Skin Care Inc. (202908021)

Name	Address	ID/FEI	Business Operations
Establishment
CSR Cosmetic Solutions		243501959	manufacture(68327-061)

Revised: 12/2017

Document Id: 60294c50-c97b-a737-e053-2a91aa0a0b2b

Set id: 309e9b7c-eece-4730-b795-96de518ae4d9

Version: 2

Effective Time: 20171212

Cover FX Skin Care Inc.