CORAL ISLE SPF 50 MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion 
Derma Care Research Labs, LLC

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Coral Isle SPF 50 Mineral Lotion

Active Ingredients

Titanium Dioxide 4.4%, Zinc Oxide 4%

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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:

Sun protection measures: spending time n 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 measure including:

Inactive Ingredients

Water, ethylhexyl palmitate, C12-15 alkyl benzoate, styrene/acrylates copolymer, glycerin, sorbitan olivate, cetyl PEG/PPG-10/1 dimethicone, dimethicone, aluminum starch octenylsuccinate, sodium chloride, silica, aloe barbadensis leaf extract, cucumis sativus (cucumber) fruit extract, mentha piperita (peppermint) leaf extract, punica granatum fruit juice, oryza sativa (rice) bran water, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grade) seed extract, camellia sinensis leaf extract, ethylhexylglycerin, propanediol, disodium EDTA, phenoxyethanol, alumina, hydrogen dimethicone

Label

Coral Isle SPF 50 Mineral Sunscreen, 2 oz, NDC 72839-114-02

LABEL

LABEL

Coral Isle Baby SPF 50 Mineral, 2 oz, NDC 72839-114-12

LabelLabel

Coral Isle SPF 50 Mineral Sunscreen, 6 oz, NDC 72839-114-06

LABEL

Coral Isle SPF 50 Baby Mineral Sunscreen, 6 oz, NDC 72839-114-16

LABEL

CORAL ISLE SPF 50 MINERAL SUNSCREEN 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ROSEMARY (UNII: IJ67X351P9)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
CUCUMBER (UNII: YY7C30VXJT)  
POMEGRANATE JUICE (UNII: 99S671U9KB)  
RICE BRAN, DEFATTED (UNII: H6597RO5A2)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-114-06170 g in 1 TUBE; Type 0: Not a Combination Product01/02/2024
2NDC:72839-114-1257 g in 1 TUBE; Type 0: Not a Combination Product01/02/2024
3NDC:72839-114-0257 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2024
4NDC:72839-114-16170 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/23/2023
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(72839-114)

Revised: 1/2024
Document Id: 0dfb66d6-5b7d-638f-e063-6294a90a2331
Set id: 0aafab44-0481-2a22-e063-6294a90abef2
Version: 2
Effective Time: 20240102
 
Derma Care Research Labs, LLC