Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30

Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30 by

Drug Labeling and Warnings

Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30 by is a Otc medication manufactured, distributed, or labeled by Odacite Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ODACITE SUN GUARDIAN OCEANIC GLACIAL WATER DAY CREME SPF30- zinc oxide, titanium dioxide cream 
Odacite Inc

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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Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30

DRUG FACTS

Active Ingredient

Zinc Oxide, 22%

Titanium Dioxide, 2.3%

Purpose

Sunscreeen

Uses:

Helps prevent sunburn if used as directed.

Warnings:

For external use only

Do not use

• on broken skin

When using this product

• avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor

• if rash occurs

Keep out of reach of children.

If swallowed, call a poison control centre or get medical help right away.

Directions:

Apply 15 minutes before sun exposure

• Reapply at least every 2 hours
• For Children less than 6 months, consult a doctor 
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and  early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & other sun protection measures  including limiting time in the sun and wearing long-sleeved shirts, pants, hats, & sunglasses.

Inactive Ingredients:

Sea Silt Extract, Aloe Barbadensis [Aloe] Leaf Juice*, Propanediol, Caprylic/ Capric Triglyceride*, Undecane, Glycerin, Glyceryl Stearate SE, Tridecane, Myristyl Alcohol, Helianthus Annuus [Sunflower] Seed Oil*, Brassica Campestris/ Aleurites Fordi Oil Copolymer, Tocopherols [Vitamin E], Camellia Sinensis [Green Tea] Leaf Extract, Jojoba Esters, Calendula Officinalis [Calendula] Flower Extract*, Myristyl Glucoside, Arachidyl Alcohol, Stearyl Alcohol, Behenyl Alcohol, Alumina, Arachidyl Glucoside, Xanthan Gum, Salicylic Acid, Benzyl Alcohol, Sorbic Acid | *Organic

Other Info:

Questions? CONTACT@ODACITE.COM

Package Labeling:

ODACITE SUN GUARDIAN OCEANIC GLACIAL WATER DAY CREME SPF30 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82088-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
UNDECANE (UNII: JV0QT00NUE)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TRIDECANE (UNII: A3LZF0L939)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
ALUMINUM OXIDE (UNII: LMI26O6933)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
XANTHAN GUM (UNII: TTV12P4NEE)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82088-001-01	1 in 1 BOX	05/18/2021	09/30/2023
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/18/2021	09/30/2023

Labeler - Odacite Inc (079682742)

Revised: 6/2023

Document Id: ff227102-839b-39d6-e053-6394a90af9c1

34390-5

Set id: 42bf3594-356f-4851-bc3c-f683c7174508

Version: 3

Effective Time: 20230627