SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

Sun Bum Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sun Bum Mineral Sunscreen Broad Spectrum 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 ingredient

Zinc oxide 20%

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.

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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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

Other information

protect this product from excessive heat and direct sun.

Inactive ingredients

water, cocos nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, methyl dihydroabietate, butyrospermum parkii (shea butter), capryloyl glycerin/sebacic acid copolymer, sodium stearoyl glutamate, cetearyl alcohol, arachidyl alcohol, coco glucoside, tocopherol, theobroma cacao (cocoa) seed butter, cetyl alcohol, behenyl alcohol, bisabolol, arachidyl glucoside, microcrystalline cellulose, cellulose gum, sodium hyaluronate, sodium gluconate, phenoxyethanol, citric acid, ethylhexylglycerin, polyhydroxystearic acid

Questions?

1-877-978-6286

Package Labeling:

Package Labeling:69039-623-02

INGREDIENTS AND APPEARANCE

SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-623
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
COCO GLUCOSIDE (UNII: ICS790225B)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
CETYL ALCOHOL (UNII: 936JST6JCN)
DOCOSANOL (UNII: 9G1OE216XY)
LEVOMENOL (UNII: 24WE03BX2T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-623-01	88 mL in 1 TUBE; Type 0: Not a Combination Product	02/22/2021
2	NDC: 69039-623-02	30 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/22/2021

Labeler - Sun Bum LLC (028642574)