OCEAN SAFE SUNSCREEN- titanium dioxide cream 
Naturally Uncommon, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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OCEAN SAFE SUNSCREEN



Broad Spectrum UVA/UVB Water-Resistant 80 Minutes



SAFE FOR FACE & BODY



SENSITIVE SKIN FORMULA



SWEAT RESISTANT



FRAGRANCE FREE



HIGH PERFORMANCE MINERAL BASED SUNSCREEN



3 FL OZ/ 88 ML

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.

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.

image description

OCEAN SAFE SUNSCREEN 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80325-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE88 mg  in 88 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80325-003-0188 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/01/2022
Labeler - Naturally Uncommon, LLC (044473410)
Establishment
NameAddressID/FEIBusiness Operations
Stream2Sea, LLC052920828manufacture(80325-003)

Revised: 6/2022
Document Id: e2192ce7-1fdb-80d1-e053-2a95a90a6ef8
Set id: 3a5a1871-0a1a-4387-b2af-1a3338101e5b
Version: 2
Effective Time: 20220623
 
Naturally Uncommon, LLC