CORAL ISLE SPF 50 MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion

Coral Isle SPF 50 Mineral Sunscreen by

Drug Labeling and Warnings

Coral Isle SPF 50 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC, Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

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:

• 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, 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

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

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

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

INGREDIENTS AND APPEARANCE

CORAL ISLE SPF 50 MINERAL SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-114-06	170 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2024
2	NDC: 72839-114-12	57 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2024
3	NDC: 72839-114-02	57 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2024
4	NDC: 72839-114-16	170 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/23/2023

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(72839-114)