SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30 Oxybenzone free/Octinoxate free

SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30 Oxybenzone free/Octinoxate free

Drug Labeling and Warnings

Drug Details

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2000DL-CL30- promo spf30 lotion 
Tropical Enterprises International, Inc.

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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SPF30 BROAD SPECTRUM LOTION
FORMULA #2000-DL-CL30
Oxybenzone free/Octinoxate free

Directions: Apply liberally and evenly 15 minutes before sun exposure.

Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immedaitely after towel drying.

For use on children under 6 months: consult a physician

Inactive Ingredients: Acrylic Polymer, Diazolidinyl Urea, Disodium EDTA, Hypromellose, Methylparaben, Propylene Glycol, Propylparaben, PPG-15 Stearyl Ether Benzoate, Triethanolamine, Water

Uses: Helps prevent sunburn.

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Purpose:

Sunscreen

Active Ingredients:

Octocrylene 7%, Octinoxate 6.5%

Oxybenone 5.5 %, Octisalate 4%

WARNINGS: Skin Cancer/ Sking Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging.

For external use only. Do not use on damaged or broken skin.

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor if irritation or rash develops or persists.

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

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2000DL-CL30 
promo spf30 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58418-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene8 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
17-HYDROXYSTEARIC ACID (UNII: O0217BD3D2)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SORBETH-12 HEXAOLEATE (UNII: F3ECF77W74)  
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DILINOLEIC ACID/PROPANEDIOL COPOLYMER (UNII: VI8BUP90UI)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
GLATIRAMER ACETATE (UNII: 5M691HL4BO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58418-002-1010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2018
2NDC: 58418-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
3NDC: 58418-002-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
4NDC: 58418-002-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
5NDC: 58418-002-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
6NDC: 58418-002-80240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
7NDC: 58418-002-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
8NDC: 58418-002-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
9NDC: 58418-002-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
10NDC: 58418-002-283840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
11NDC: 58418-002-001.5 mL in 1 PACKET; Type 0: Not a Combination Product02/02/2020
12NDC: 58418-002-70211200 mL in 1 DRUM; Type 0: Not a Combination Product02/02/2020
13NDC: 58418-002-3240960 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product02/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2018
Labeler - Tropical Enterprises International, Inc. (091986179)
Registrant - Tropical Enterprises International, Inc. (091986179)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Enterprises International, Inc.091986179relabel(58418-002) , repack(58418-002) , pack(58418-002) , manufacture(58418-002)

Revised: 2/2020
 
Tropical Enterprises International, Inc.


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