DTRT Boys Be Bold BB SPF 25 by Have & Be Co., Ltd. / Kolmar Korea Co., Ltd. 49404-134_Deactivation

DTRT Boys Be Bold BB SPF 25 by

Drug Labeling and Warnings

DTRT Boys Be Bold BB SPF 25 by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DTRT BOYS BE BOLD BB SPF 25- titanium dioxide, octinoxate, zinc oxide cream 
Have & Be Co., Ltd.

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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49404-134_Deactivation

Titanium Dioxide 6.38%

Octinoxate 3.00%

Zinc Oxide 1.92%

Sunscreen

Helps prevent sunburn

If used as directed with other sun protection meausres (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun

• Apply liberally 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating

• Reapply 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 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 am - 2 pm

– Wear long-sleeved shirts, pants, hats and
sunglasses

• Ask a doctor to use for children under 6 months

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.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Cyclopentasiloxane, Dipropylene Glycol, Glycerin, PEG-10 Dimethicone, Talc, Niacinamide, Isoeicosane, Betaine, Disteardimonium Hectorite, Iron Oxides, Magnesium Sulfate, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, C12-14 Pareth-3, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Methicone, Aluminum Hydroxide, Aluminum Stearate, Methylparaben, Betula Alba Juice, Fragrance, Lavandula Angustifolia (Lavender) Flower Water, Oenothera Biennis (Evening Primrose) Oil, Propylparaben, Tocopheryl Acetate, Dimethicone, Butylparaben, Adenosine, Aloe Barbadensis Leaf Juice

Protect the product in this container from excessive heat and direct sunlight

You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

DTRT BOYS BE BOLD BB SPF 25 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.914 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.9 mg  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.576 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TALC (UNII: 7SEV7J4R1U)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOEICOSANE (UNII: AR294KAG3T)
BETAINE (UNII: 3SCV180C9W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
C12-14 PARETH-3 (UNII: 93RY22U87E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
METHYLPARABEN (UNII: A2I8C7HI9T)
BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADENOSINE (UNII: K72T3FS567)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-134-02	1 in 1 CARTON	06/26/2017	01/16/2020
1	NDC: 49404-134-01	30 mL 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 not final	part352	10/21/2016	01/16/2020

Labeler - Have & Be Co., Ltd. (690400408)

Registrant - Have & Be Co., Ltd. (690400408)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(49404-134)

Revised: 1/2020

Document Id: 9c4bf0e6-3012-2119-e053-2995a90a71ac

34390-5

Set id: cbbc004b-da93-45e8-a3a7-a7c3311cd377

Version: 2

Effective Time: 20200116

 

Have & Be Co., Ltd.