BURTS BEES CALMING DAY SPF30- zinc oxide lotion

Burts Bees Calming Day by

Drug Labeling and Warnings

Burts Bees Calming Day by is a Otc medication manufactured, distributed, or labeled by Burts Bees. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 16.9%

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.

Do not use on broken or damaged 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 product is swalloed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply

​Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly us a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants, hats and sunglasses . Children under 6 months: ask a doctor.

Other Information

Protect this product from excessive hear and direct sun.

Inactive Ingredients:

water, caprylic/capric triglyceride, glycerin, polyglyceryl-6 stearate, C13-15 alkane, pentylene glycol, mica, c15-19 alkane, silica, cetearyl nonanoate, inulin, squalane, polyhydroxystearic acid, carthamus tinctorius (safflower) seed oil, simmondsia chinensis (jojoba) seed oil, aloe barbadensis leaf juice, honey, argania spinosa kernel oil, saccharomyces ferment, beeswax, oryza sativa (rice) extract, acacia senegal gum, tocopheryl acetate, polyglyceryl-6 behenate, stearyl alcohol, cetyl alcohol, xanthan gum, glyceryl laurate, sodium PCA, sodium citrate, citric acid, sodium phytate, bisabolol, potassium sorbate, fructose, glucose, inositol, sucrose, trehalose, myristyl alcohol, arachidyl alcohol, benzoic acid, sodium benxoate, hydroxyacetophenone  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURTS BEES CALMING DAY  SPF30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-492
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	16.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
YELLOW WAX (UNII: 2ZA36H0S2V)
ACACIA (UNII: 5C5403N26O)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LEVOMENOL (UNII: 24WE03BX2T)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
HONEY (UNII: Y9H1V576FH)
RICE GERM (UNII: 7N2B70SFEZ)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
C13-15 ALKANE (UNII: 114P5I43UJ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MICA (UNII: V8A1AW0880)
C15-19 ALKANE (UNII: CI87N1IM01)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
INULIN (UNII: JOS53KRJ01)
SQUALANE (UNII: GW89575KF9)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE (UNII: V5VD430YW9)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
GLYCERYL LAURATE (UNII: Y98611C087)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-492-01	1 in 1 CARTON	10/01/2021
1		51 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	10/01/2021

Labeler - Burts Bees (613480946)