BABY NOURISHING MINERAL- titanium dioxide, zinc oxide lotion

Baby Nourishing Mineral by

Drug Labeling and Warnings

Baby Nourishing Mineral by is a Otc medication manufactured, distributed, or labeled by BURT'S BEES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 2.8%

Zinc Oxide 13%

PURPOSE

Sunscreen

INDICATIONS & USAGE

• Helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused but 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a Doctor if a rash occurs.

DOSAGE & ADMINISTRATION

• Apply liberally 15 minutes before sun exposure.

Reapply

• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every two hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a suncreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months, ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: water, dicaprylyl ether, carthamus tinctorius (safflower) oleosomes, caprylic/capric triglyceride, glycerin, beeswax, cetyl alcohol, nelumbo nucifera flower wax, lonicera japonica (honeysuckle) flower extract, lonicera caprifolium (honeysuckle) flower extract, glycine soja (soybean) oil, prunus armeniaca (apricot) fruit extract, pyrus malus (apple) fruit extract, cocos nucifera (coconut) fruit extract, coffea arabica (coffee) seed extract, dipteryx odorata seed extract, vanilla planifolia fruit extract, isostearic acid, polyhydroxystearic acid, alumina, lecithin, polyglyceryl-3 polyricinoleate, gluconic acid, tocopherol, citric acid, stearic acid, sodium phytate, alcohol, phenoxyethanol, sodium benzoate, potassium sorbate

Other Information

Protect this product from excessive heat and direct sun.

QUESTIONS

(800) 849-7112 or www.burtsbees.com

PRINCIPAL DISPLAY PANEL

Burt's Bees Baby

nourishing

mineral

sunscreen

with Vitamin E

SPF 30

Water Resistant (40 mins)

Broad Spectrun SPF 30

(UVA/UVB Protection)

INGREDIENTS AND APPEARANCE

BABY NOURISHING MINERAL 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT (UNII: 3RT3536DHY)
APRICOT (UNII: 269CJD5GZ9)
APPLE (UNII: B423VGH5S9)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)
VANILLA (UNII: Q74T35078H)
ALCOHOL (UNII: 3K9958V90M)
SOYBEAN OIL (UNII: 241ATL177A)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LONICERA JAPONICA TOP (UNII: 60Q6UP226V)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIDECYL ETHER (UNII: DA81HI310Z)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
NELUMBO NUCIFERA FLOWER WAX (UNII: U01S6C427I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOSTEARIC ACID (UNII: X33R8U0062)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLUCONIC ACID (UNII: R4R8J0Q44B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LONICERA CAPRIFOLIUM FLOWERING TOP (UNII: 1X0T378SXY)
PHYTATE SODIUM (UNII: 88496G1ERL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-037-01	85 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2016

Labeler - BURT'S BEES (613480946)