OCEAN SAFE SUNSCREEN- titanium dioxide cream

OCEAN SAFE SUNSCREEN by

Drug Labeling and Warnings

OCEAN SAFE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Naturally Uncommon, LLC, Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS Active Ingredients

8.8% Titanium Dioxide

Purpose

(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 minutes before sun exposure.
■ Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
■ For children under 6 months of age; ask a doctor.

ASK DOCTOR

OTHER INFO

Protect this product from excessive heat and sunlight.

INACTIVE INGREDIENTS

Deionized Water, Aqueous Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, Olea Europa (Olive) Leaf*, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe) Leaf Juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhydroxystearic 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 and Sorbic Acid.
*Organic Ingredients.

MANUFACTURED FOR
NATURALLY UNCOMMON, LLC
ATKINSON, NH03811

fishermanhandscrub.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OCEAN SAFE SUNSCREEN-88 ML - NDC-80325-003-01- TUBE LABEL.

INGREDIENTS AND APPEARANCE

OCEAN SAFE SUNSCREEN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80325-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HOLY BASIL LEAF (UNII: SCJ765569P)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ALOE (UNII: V5VD430YW9)
TRICAPRIN (UNII: O1PB8EU98M)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80325-003-01	88 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/01/2022

Labeler - Naturally Uncommon, LLC (044473410)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(80325-003)