SUN BUM HIGH PERFORMANCE SUNSCREEN SIGNATURE CLEAR 50 NEW- octocrylene, octisalate, zinc oxide lotion SUN BUM HIGH PERFORMANCE SUNSCREEN SIGNATURE CLEAR 50- octocrylene, octisalate, zinc oxide lotion

Sun Bum High Performance Sunscreen Signature Clear 50 by

Drug Labeling and Warnings

Sun Bum High Performance Sunscreen Signature Clear 50 by is a Otc medication manufactured, distributed, or labeled by Sun Bum, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octocrylene 10%, Octisalate 5%, Zinc Oxide 10%

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 immediately.

Warnings

​Keep Out Of Reach Of Children

Directions

shake well before use

apply liberally 15 minutes before sun exposure

reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

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

Directions

shake well before use

apply liberally 15 minutes before sun exposure

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

water, C12-15 alkyl benzoate, trimethylpentanediol/adipic acid copolymer, butyrospermum parkii (shea) butter, glycerin, polyester-8, arachidyl alcohol, panthenol, aloe barbadensis leaf juice, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, beeswax, behenyl alcohol, arachidyl glucoside, sorbitan oleate, sorbitol, lecithin, xanthan gum, oleic acid, glyceryl caprylate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, Triethoxycaprylylsilane, disodium EDTA, phenoxyethanol, caprylyl glycol, ethylhexylglycerin

Questions?

1-877-978-6286

Sun Bum High Performance Sunscreen Signature Clear 50 Primary Artwork

Sun Bum High Performance Sunscreen Signature Clear 50 New Primary Artwork

INGREDIENTS AND APPEARANCE

SUN BUM HIGH PERFORMANCE SUNSCREEN SIGNATURE CLEAR 50 NEW 
octocrylene, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PANTHENOL (UNII: WV9CM0O67Z)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SORBITAN OLEATE (UNII: 06XEA2VD56)
OLEIC ACID (UNII: 2UMI9U37CP)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
BEESWAX (UNII: 2ZA36H0S2V)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-708-02	1 in 1 BOX	01/01/2025
1	NDC: 69039-708-01	947 mL in 1 BOTTLE, PLASTIC; 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	01/01/2025

SUN BUM HIGH PERFORMANCE SUNSCREEN SIGNATURE CLEAR 50 
octocrylene, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-707
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PANTHENOL (UNII: WV9CM0O67Z)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SORBITAN OLEATE (UNII: 06XEA2VD56)
OLEIC ACID (UNII: 2UMI9U37CP)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
BEESWAX (UNII: 2ZA36H0S2V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-707-02	1 in 1 BOX	01/01/2025
1	NDC: 69039-707-01	947 mL in 1 BOTTLE, PLASTIC; 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	01/01/2025

Labeler - Sun Bum, LLC (028642574)