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NDC 82088-0001-01 Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30 23; 220 mg/mL; mg/mL Details
Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30 23; 220 mg/mL; mg/mL
Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Odacite Inc. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
| NDC | 82088-0001 |
|---|---|
| Product ID | 82088-001_eb3de85f-ffdb-1e9f-e053-2995a90a8985 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Odacite Sun Guardian Oceanic Glacial Water Day Creme SPF30 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ZINC OXIDE, TITANIUM DIOXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 23; 220 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
| Labeler Name | Odacite Inc |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 82088-0001-01 (82088000101)
| NDC Package Code | 82088-001-01 |
|---|---|
| Billing NDC | 82088000101 |
| Package | 1 BOTTLE in 1 BOX (82088-001-01) / 50 mL in 1 BOTTLE |
| Marketing Start Date | 2021-05-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 42bf3594-356f-4851-bc3c-f683c7174508 Details
Warnings:
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:
INGREDIENTS AND APPEARANCE
| ODACITE SUN GUARDIAN OCEANIC GLACIAL WATER DAY CREME SPF30
zinc oxide, titanium dioxide cream |
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| Labeler - Odacite Inc (079682742) |
Revised: 10/2022
Document Id: eb3de85f-ffdb-1e9f-e053-2995a90a8985
Set id: 42bf3594-356f-4851-bc3c-f683c7174508
Version: 2
Effective Time: 20221017