CORAL CARE SPF 30 SUNSCREEN- titanium dioxide 8.8% lotion

Coral Care SPF 30 Sunscreen by

Drug Labeling and Warnings

Coral Care SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Stream2Sea. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 8.8%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at lease every 2 hours. For children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Water/Aqua, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe)* Leaf Juice, Cocoglycerides, Glycerin, Camellia Sinensis (Green Tea)* Leaf Extract, Ocimum Tenuiflorum (Tulsi)* Extract, Alaria Esculenta (Wakame Seaweed)* Extract, Olea Europaea (Olive)* Leaf Extract, Sorbitan Olivate, Cetyl Palmitate, Cetearyl Olivate, Methylcellulose, Cetearyl Alcohol, Polyhydroxystearic Acid, Acrylates Copolymer, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Stearic Acid, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Maris Aqua (Sea Water).

*Organic Ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORAL CARE SPF 30 SUNSCREEN 
titanium dioxide 8.8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SALICYLIC ACID (UNII: O414PZ4LPZ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINA (UNII: LMI26O6933)
COCOGLYCERIDES (UNII: ISE9I7DNUG)
GLYCERIN (UNII: PDC6A3C0OX)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
SORBIC ACID (UNII: X045WJ989B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
METHYLCELLULOSE (UNII: Z944H5SN0H)
HOLY BASIL LEAF (UNII: SCJ765569P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69555-032-02	75 mL in 1 TUBE; Type 0: Not a Combination Product	11/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/19/2024

Labeler - Stream2Sea (052920828)

Registrant - Stream2Sea (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea		052920828	manufacture(69555-032)