DTRT Get Ready BB SPF 50 by Have & Be Co., Ltd. / Cosmax, Inc. 49404-135_Deactivation

DTRT Get Ready BB SPF 50 by

Drug Labeling and Warnings

DTRT Get Ready BB SPF 50 by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DTRT GET READY BB SPF 50- octinoxate, octisalate, zinc oxide, titanium dioxide 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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49404-135_Deactivation

Octinoxate 7.50%

Octisalate 5.00%

Zinc Oxide 4.90%

Titanium Dioxide 2.90%

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, Cyclohexasiloxane, Glycerin, PEG-10 Dimethicone, Dimethicone, Dipropylene Glycol, Niacinamide, Methyl Methacrylate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Isoamyl p-Methoxycinnamate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Iron Oxides, Stearic Acid, Phenoxyethanol, Fragrance, Glyceryl Caprylate, Caprylyl Glycol, Talc, Caffeine, Adenosine, Lavandula Angustifolia (Lavender) Water, Sea Water, Sucrose, Butylene Glycol, Salix Nigra (Willow) Bark Extract, Arginine, PCA, Serine, Alanine, Polyquaternium-51, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Malva Sylvestris (Mallow) Extract, Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Veronica Officinalis Extract, Threonine, Benzyl Alcohol, Mourera Fluviatilis Extract, Portulaca Oleracea Extract, Dehydroacetic Acid

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

image description

DTRT GET READY BB SPF 50 
octinoxate, octisalate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49404-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.5 mg  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.47 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.87 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
AMILOXATE (UNII: 376KTP06K8)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CAFFEINE (UNII: 3G6A5W338E)  
ADENOSINE (UNII: K72T3FS567)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SUCROSE (UNII: C151H8M554)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SALIX NIGRA BARK (UNII: QU52J3A5B3)  
ARGININE (UNII: 94ZLA3W45F)  
PIDOLIC ACID (UNII: SZB83O1W42)  
SERINE (UNII: 452VLY9402)  
ALANINE (UNII: OF5P57N2ZX)  
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)  
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
PRIMULA VERIS (UNII: W6LFQ57E4M)  
THREONINE (UNII: 2ZD004190S)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PURSLANE (UNII: M6S840WXG5)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49404-135-021 in 1 CARTON06/26/201701/16/2020
1NDC: 49404-135-0130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/26/201701/16/2020
Labeler - Have & Be Co., Ltd. (690400408)
Registrant - Have & Be Co., Ltd. (690400408)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(49404-135)

Revised: 1/2020
 
Have & Be Co., Ltd.