MINERAL SPF 30 WHIPPED SUNSCREEN- titanium dioxide, zinc oxide lotion

Mineral SPF 30 Whipped Sunscreen by

Drug Labeling and Warnings

Mineral SPF 30 Whipped Sunscreen 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

Titanium dioxide 7.7%

Zinc oxide 6.9%

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

Flammable: do you not use near heat, flame, or while smoking

Do not use

on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F / 50°C.

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
• invert can and dispense liberally and spread evenly by hand 15 minutes before sun exposure
• do not dispense directely on face. Dispense into hands then apply to face
• do not apply in windy conditions 
• use in well-ventilated area
• 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

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, propane, n-butane, isobutane, cococaprylate, butyloctyl salicylate, PEG-8 stearate, glyceryl stearate, cetearyl alcohol, sorbitan oleate, helianthus annuus (sunflower) seed extract, xylitylglucoside, anhydroxylitol, xylitol, glycerin, xanthan gum, polyhydroxystearic acid, triethoxycaprylylsilane, silica, dimethicone, dehydroacetic acid, benzyl alcohol, fragrance

Questions?

call 1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

MINERAL SPF 30 WHIPPED SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANE (UNII: T75W9911L6)
BUTANE (UNII: 6LV4FOR43R)
ISOBUTANE (UNII: BXR49TP611)
COCO-CAPRYLATE (UNII: 4828G836N6)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-281-00	170 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2019

Labeler - Sun Bum LLC (028642574)