Label: BURTS BEES CALMING DAY SPF30- zinc oxide lotion
- NDC Code(s): 26052-492-01
- Packager: Burts Bees
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 31, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Uses
- Warnings
- Keep out of reach of children.
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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
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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
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INGREDIENTS AND APPEARANCE
BURTS BEES CALMING DAY SPF30
zinc oxide lotionProduct 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)
