NATURIUM PHYTO-GLOW LIP BALM SPF 45-OASIS- avobenzone, homosalate, octisalate cream NATURIUM PHYTO-GLOW LIP BALM SPF 45-ESCAPE- avobenzone, homosalate, octisalate cream NATURIUM PHYTO-GLOW LIP BALM SPF 45-PARADISE- avobenzone, homosalate, octisalate cream NATURIUM PHYTO-GLOW LIP BALM SPF 45-GETAWAY- avobenzone, homosalate, octisalate cream

Naturium Phyto-Glow Lip Balm SPF 45-Getaway by

Drug Labeling and Warnings

Naturium Phyto-Glow Lip Balm SPF 45-Getaway by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3%

Homosalate 3%

Octisalate 5%

Purpose

Sunscreen

Uses

• 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.

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 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 Board Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m.-2 p.m., wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor.

Other Information

• Protect the product in this container from excessive heat and direct sun.

InactiveIngredients

Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Aroma/Flavor, Polyglyceryl-2 Diisostearate, Butyrospermum Parkii (Shea) Butter, Cera Microcristallina/Microcrystalline Wax/Cire Microcristalline, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Synthetic Wax, Mica, Squalane, Theobroma Grandiflorum Seed Butter, Siraitia Grosvenorii Fruit Extract, Tocopherol, Citric Acid, BHT, Carvone, Cinnamal, Eugenol, Limonene, Menthol, Methyl Salicylate, Vanillin.

Questions?

1-888-315-9814

Package Labeling:

Packaging Label

Packaging Label

Packaging Label

INGREDIENTS AND APPEARANCE

NATURIUM PHYTO-GLOW LIP BALM SPF 45-OASIS 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMAL (UNII: SR60A3XG0F)
RED 6 (UNII: 481744AI4O)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
YELLOW 5 (UNII: I753WB2F1M)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
CITRIC ACID (UNII: 2968PHW8QP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BHT (UNII: 1P9D0Z171K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TOCOPHEROL (UNII: R0ZB2556P8)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)
EUGENOL (UNII: 3T8H1794QW)
VANILLIN (UNII: CHI530446X)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CARVONE (UNII: 75GK9XIA8I)
MICA (UNII: V8A1AW0880)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
MENTHOL (UNII: L7T10EIP3A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BLUE 1 LAKE (UNII: J9EQA3S2JM)
RED 7 (UNII: ECW0LZ41X8)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-137-01	1 in 1 CARTON	06/09/2025
1		10 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 Drug	M020	06/09/2025

NATURIUM PHYTO-GLOW LIP BALM SPF 45-ESCAPE 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMAL (UNII: SR60A3XG0F)
RED 6 (UNII: 481744AI4O)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
YELLOW 5 (UNII: I753WB2F1M)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
CITRIC ACID (UNII: 2968PHW8QP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BHT (UNII: 1P9D0Z171K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TOCOPHEROL (UNII: R0ZB2556P8)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)
EUGENOL (UNII: 3T8H1794QW)
VANILLIN (UNII: CHI530446X)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CARVONE (UNII: 75GK9XIA8I)
MICA (UNII: V8A1AW0880)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
MENTHOL (UNII: L7T10EIP3A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BLUE 1 LAKE (UNII: J9EQA3S2JM)
RED 7 (UNII: ECW0LZ41X8)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-139-01	1 in 1 CARTON	06/09/2025
1		10 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 Drug	M020	06/09/2025

NATURIUM PHYTO-GLOW LIP BALM SPF 45-PARADISE 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMAL (UNII: SR60A3XG0F)
RED 6 (UNII: 481744AI4O)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
YELLOW 5 (UNII: I753WB2F1M)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
CITRIC ACID (UNII: 2968PHW8QP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BHT (UNII: 1P9D0Z171K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TOCOPHEROL (UNII: R0ZB2556P8)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)
EUGENOL (UNII: 3T8H1794QW)
VANILLIN (UNII: CHI530446X)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CARVONE (UNII: 75GK9XIA8I)
MICA (UNII: V8A1AW0880)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
MENTHOL (UNII: L7T10EIP3A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BLUE 1 LAKE (UNII: J9EQA3S2JM)
RED 7 (UNII: ECW0LZ41X8)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-138-01	1 in 1 CARTON	06/09/2025
1		10 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 Drug	M020	06/09/2025

NATURIUM PHYTO-GLOW LIP BALM SPF 45-GETAWAY 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-136
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
RED 6 (UNII: 481744AI4O)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
BHT (UNII: 1P9D0Z171K)
YELLOW 5 (UNII: I753WB2F1M)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
CITRIC ACID (UNII: 2968PHW8QP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TOCOPHEROL (UNII: R0ZB2556P8)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)
EUGENOL (UNII: 3T8H1794QW)
VANILLIN (UNII: CHI530446X)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CARVONE (UNII: 75GK9XIA8I)
MICA (UNII: V8A1AW0880)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
MENTHOL (UNII: L7T10EIP3A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
CINNAMAL (UNII: SR60A3XG0F)
BLUE 1 LAKE (UNII: J9EQA3S2JM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
RED 7 (UNII: ECW0LZ41X8)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-136-01	1 in 1 CARTON	06/09/2025
1		10 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 Drug	M020	06/09/2025

Labeler - e.l.f. Cosmetics, Inc. (093902816)