RMS SUNCOVERUP SUPER TINT SPF 50 TAWNY- zinc oxide lotion RMS SUNCOVERUP SUPER TINT SPF 50 TAN- zinc oxide lotion RMS SUNCOVERUP SUPER TINT SPF 50 SAND- zinc oxide lotion RMS SUNCOVERUP SUPER TINT SPF 50 MOCHA- zinc oxide lotion RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY- zinc oxide lotion RMS SUNCOVERUP SUPER TINT SPF 50 SPICE- zinc oxide lotion RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE- zinc oxide lotion

RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE by

Drug Labeling and Warnings

RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE by is a Otc medication manufactured, distributed, or labeled by Rms organics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 12%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protective measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well. apply liberally 15 minutes before sun exposure
• reapply: at least every 2 hours for sun protection
• use a water resistant sunscreen if swimming or sweating
• 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

Other information

• protect the product in this container from excessive heat and direct sun
• may stain fabrics

Inactive ingredients

Water/Aqua/Eau, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Glycerin, Polyglyceryl-3 Polyricinoleate, Glyceryl Oleate, Methylpropanediol, Silica, Sodium Chloride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Diatomaceous Earth/Solum Diatomeae/Terra de diatomees, Lecithin, Ethylhexyl Palmitate, Ethylhexyl Stearate, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Phenylpropanol, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (non-GMO), Olea Europaea (Olive) Oil Unsaponifiables, Squalane (vegetable), Tetrasodium Glutamate Diacetate, Niacinamide, *Calendula Officinalis (Marigold) Flower Extract, *Curcuma Longa (Turmeric) Root Powder, *Equisetum Arvense (Horsetail) Leaf Extract, *Hemidesmus Indicus (Country Sarsaparilla) Root Powder, *Hypericum Perforatum (St. John's Wort) Flower Extract, Pisum Sativum (Pea) Seed Extract, *Withania Somnifera (Ashwagandha) Root Extract, *Glycyrrhiza Glabra (Licorice) Root, *Olea Europaea (Olive) Leaf Extract, Benzyl Alcohol, Chenopodium Quinoa Seed Extract, Potassium Sorbate, Sodium Benzoate, Sodium Hydroxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).

*Certified Organic

Company Information

dist. by/par: RMS Organics, LLC

Charleston, SC 29407

made in the USA with quality ingredients sourced from around the world

www.rmsbeauty.com

Product Packaging - Mahogany

Product Packaging - Mocha

Product Packaging - Sand

Product Packaging - Spice

Product Packaging - Tan

Product Packaging - Tawny

Product Packaging - Toffee

INGREDIENTS AND APPEARANCE

RMS SUNCOVERUP SUPER TINT SPF 50 TAWNY 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83249-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TURMERIC (UNII: 856YO1Z64F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
JOJOBA OIL (UNII: 724GKU717M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEA (UNII: W4X7H8GYFM)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83249-015-01	1 in 1 CARTON	09/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

RMS SUNCOVERUP SUPER TINT SPF 50 TAN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83249-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TURMERIC (UNII: 856YO1Z64F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
JOJOBA OIL (UNII: 724GKU717M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEA (UNII: W4X7H8GYFM)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83249-014-01	1 in 1 CARTON	09/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

RMS SUNCOVERUP SUPER TINT SPF 50 SAND 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83249-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TURMERIC (UNII: 856YO1Z64F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
JOJOBA OIL (UNII: 724GKU717M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEA (UNII: W4X7H8GYFM)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83249-012-01	1 in 1 CARTON	09/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

RMS SUNCOVERUP SUPER TINT SPF 50 MOCHA 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83249-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TURMERIC (UNII: 856YO1Z64F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
JOJOBA OIL (UNII: 724GKU717M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEA (UNII: W4X7H8GYFM)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83249-011-01	1 in 1 CARTON	09/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83249-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENYLPROPANOL (UNII: 0F897O3O4M)
JOJOBA OIL (UNII: 724GKU717M)
NIACINAMIDE (UNII: 25X51I8RD4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEA (UNII: W4X7H8GYFM)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TURMERIC (UNII: 856YO1Z64F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83249-010-01	1 in 1 CARTON	09/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

RMS SUNCOVERUP SUPER TINT SPF 50 SPICE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83249-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TURMERIC (UNII: 856YO1Z64F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
JOJOBA OIL (UNII: 724GKU717M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEA (UNII: W4X7H8GYFM)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83249-013-01	1 in 1 CARTON	09/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83249-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TURMERIC (UNII: 856YO1Z64F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
JOJOBA OIL (UNII: 724GKU717M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEA (UNII: W4X7H8GYFM)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83249-016-01	1 in 1 CARTON	09/01/2024
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

Labeler - Rms organics LLC (031351949)