BEE BALD SMOOTH PLUS DAILY MOISTURIZER SPF 30 SUNSCREEN- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 2.7%, oxybenzone 6% lotion
Derma Care Research Labs, LLC

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.

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Bee Bald Smooth Plus Daily Moisturizer SPF 30 Sunscreen Lotion

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 2.7%, Oxybenzone 6%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes 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 right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 am to 2 pm
wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Polyamide-5, C10-18 Triglycerides, VP/Hexadecene Copolymer, Glycyrrhiza Glabra (Licorice) Root Extract, Lycium Barbarum (Goji Berry) Fruit Extract, Propolis Cera (Bee Pollen) Extract, Honey Extract, Tocopheryl Acetate, Polysilicone-15, Glycerin, Butylene Glycol, Propylene Glycol, Xanthan Gum, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Fragrance.

Label

BEE BALD SMOOTH PLUS DAILY MOISTURIZER SPF 30 SUNSCREEN
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 2.7%, oxybenzone 6% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72839-138
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSILICONE-15 (UNII: F8DRP5BB29)
POLYAMIDE-5 (UNII: UEM62QMW5F)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BEE POLLEN (UNII: 3729L8MA2C)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
HONEY (UNII: Y9H1V576FH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LICORICE (UNII: 61ZBX54883)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72839-138-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	01/24/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/24/2022

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Name	Address	ID/FEI	Business Operations
Establishment
Derma Care Research Labs		116817470	manufacture(72839-138)