BELLA VIDA SONTA BARBARA OCEANO SEA MINERAL TINTED SPF SERUM SPF 30

Drug Details [pdf]

OCEANO SEA MINERAL- titanium dioxide lotion
Stream2Sea, LLC

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BELLA VIDA

SONTA BARBARA

OCEANO SEA MINERAL

TINTED SPF SERUM SPF 30

Drug Facts

Active Ingredients Purpose

8.8% Titanium Dioxide (Non-Nano).........Sunscreen

Uses

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.

Directions

Apply liberally 15 mins before sun exposure.
Reapply after 80 mins of swimming, sweating or immediately after towel drying and at least every 2 hrs
For children under 6 mths of age; ask a doctor.
Keep babies and young children out of direct sunlight.

Inactive ingredients:

Deionized Water, Aqueous Extracts of Camellia Sinenis(Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)* and Olea Europa (Olive) Leaf*, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe) Leaf Juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhdroxystearic Acid, Sorbitan Olivate, Cetearyl olivate, Methylcellulose, Cocos Nucifera (Coconut) Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Iron Oxides (C.I. 77492, C.I. 77491, C.I. 77499) and Jojoba Esters *ORGANIC INGREDIENTS

Bella Vida Santa Barbara | Santa Barbara, CA | (888) 252-3552

NDC# 69555-038-50

Mfd in the USA by: Stream2Sea | Bowling Green, FL 33834

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oceano Sea Mineral Tinted SPF Serum - 1.7 oz/50ml - NDC-69555-038-50 - 50mL Bottle Label

image description

OCEANO SEA MINERAL
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-038
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	88 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HOLY BASIL LEAF (UNII: SCJ765569P)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
COCONUT OIL (UNII: Q9L0O73W7L)
STEARIC ACID (UNII: 4ELV7Z65AP)
LUVISET 360 (UNII: 05BG6GY6YK)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SORBIC ACID (UNII: X045WJ989B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69555-038-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2022	12/29/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/01/2022	12/29/2023

Labeler - Stream2Sea, LLC (052920828)

Name	Address	ID/FEI	Business Operations
Establishment
Stream2Sea, LLC		052920828	manufacture(69555-038)

Revised: 1/2024

Document Id: 0e871394-5dca-332f-e063-6294a90a90fd

Set id: 93910487-0efe-40f1-be0d-42ac816710d1

Version: 2

Effective Time: 20240109