SUN BUM SIGNATURE CLEAR SPF 50- octisalate, octocrylene, zinc oxide lotion

Sun Bum Signature Clear SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients

Octisalate 5%, Octocrylene 10%. 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 externel 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

• 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 10a.m. - 2.p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses.

Other information

• protect this product from excessive heat and direct sun. Keep outer carton for complete labeling information

Inactive ingredients

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

Questions?

1(877)978-6286

Package Labeling:44ml

Package Labeling:88ml

INGREDIENTS AND APPEARANCE

SUN BUM SIGNATURE CLEAR SPF 50 
octisalate, octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-617
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
OLEIC ACID (UNII: 2UMI9U37CP)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-617-01	44 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2020
2	NDC: 69039-617-02	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/11/2020

Labeler - Sun Bum LLC (028642574)