LIPSHADE SPF 30 HIGH FIVE- zinc oxide lipstick 
LIPSHADE SPF 30 LOVE YOU MORE- zinc oxide lipstick 
LIPSHADE SPF 30 LUCKY ME- zinc oxide lipstick 
LIPSHADE SPF 30 OBSESSED- zinc oxide lipstick 
LIPSHADE SPF 30 HEY YALL- zinc oxide lipstick 
Supergoop, 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.

----------

Lipshade SPF 30

Active Ingredients: Zinc Oxide 17.5%

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

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

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

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply (will vary depending on WR)

after XX minutes of swimming or sweating

Immediately after towel drying

at least every 2 hours

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

Children under 6 months: Ask a doctor

Hey Yall

CartonLIPSHADE

100% Mineral

Lip Color

SPF 30

Hey Y'all

High Five

LIPSHADE

100% Mineral

Lip Color

SPF30

High Five

Carton

Love You More

LIPSHADE

100%

Lip Color

SPF 30

Love you more

Carton

Lucky Me

LIPSHADE

100% Mineral

Lip Color

SPF 30

Lucky Me

Carton

Obsessed

LIPSHADE

100% Mineral

Lip Color

SPF 30

Obsessed

Carton

LIPSHADE SPF 30 HIGH FIVE 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
PEPPERMINT (UNII: V95R5KMY2B)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
SOYBEAN OIL (UNII: 241ATL177A)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
ARGAN OIL (UNII: 4V59G5UW9X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
CANDELILLA WAX (UNII: WL0328HX19)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-616-021 in 1 CARTON04/13/2023
1NDC:75936-616-013.5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/13/2023
LIPSHADE SPF 30 LOVE YOU MORE 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-617
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
D&C RED NO. 6 (UNII: 481744AI4O)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
PEPPERMINT (UNII: V95R5KMY2B)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
SOYBEAN OIL (UNII: 241ATL177A)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
ARGAN OIL (UNII: 4V59G5UW9X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
CANDELILLA WAX (UNII: WL0328HX19)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-617-021 in 1 CARTON04/13/2023
1NDC:75936-617-013.5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/13/2023
LIPSHADE SPF 30 LUCKY ME 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-618
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
D&C RED NO. 6 (UNII: 481744AI4O)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
PEPPERMINT (UNII: V95R5KMY2B)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
SOYBEAN OIL (UNII: 241ATL177A)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
ARGAN OIL (UNII: 4V59G5UW9X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
CANDELILLA WAX (UNII: WL0328HX19)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-618-021 in 1 CARTON04/13/2023
1NDC:75936-618-013.5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/13/2023
LIPSHADE SPF 30 OBSESSED 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-619
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
D&C RED NO. 6 (UNII: 481744AI4O)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
PEPPERMINT (UNII: V95R5KMY2B)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
SOYBEAN OIL (UNII: 241ATL177A)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
ARGAN OIL (UNII: 4V59G5UW9X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
CANDELILLA WAX (UNII: WL0328HX19)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-619-021 in 1 CARTON04/13/2023
1NDC:75936-619-013.5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/13/2023
LIPSHADE SPF 30 HEY YALL 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-615
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
D&C RED NO. 6 (UNII: 481744AI4O)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
PEPPERMINT (UNII: V95R5KMY2B)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
SOYBEAN OIL (UNII: 241ATL177A)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
ARGAN OIL (UNII: 4V59G5UW9X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
CANDELILLA WAX (UNII: WL0328HX19)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-615-021 in 1 CARTON04/13/2023
1NDC:75936-615-013.5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/13/2023
Labeler - Supergoop, LLC (117061743)

Revised: 4/2023
Document Id: f93dfa13-ff19-ee38-e053-6394a90aea46
Set id: f93dfa13-ff18-ee38-e053-6394a90aea46
Version: 1
Effective Time: 20230413
 
Supergoop, LLC