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NDC 55560-2201-01 ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 157 mg/mL Details
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 157 mg/mL
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Andalou naturals. The primary component is ZINC OXIDE.
Product Information
| NDC | 55560-2201 |
|---|---|
| Product ID | 55560-2201_479f3e2d-663b-4d54-be33-3de2fdc294e1 |
| 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 | ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ZINC OXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 157 |
| Active Ingredient Units | mg/mL |
| Substance Name | ZINC OXIDE |
| Labeler Name | Andalou naturals |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 55560-2201-01 (55560220101)
| NDC Package Code | 55560-2201-1 |
|---|---|
| Billing NDC | 55560220101 |
| Package | 1 TUBE in 1 CARTON (55560-2201-1) / 80 mL in 1 TUBE |
| Marketing Start Date | 2022-01-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL aa689e82-6512-46d8-aec9-269f9348d3f8 Details
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor.
- Use daily or alone under makeup.
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 and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
Inactive Ingredients
Aqua/Water/Eau, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Tetradecane, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Ectoin, Arachidyl Alcohol, Caprylyl Glycol, Diheptyl Succinate, Coco-Glucoside, Xanthan Gum, Calcium Sodium Borosilicate, Parfum (Fragrance)1, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Bisabolol2, Citric Acid, Arachidyl Glucoside, Sodium Gluconate, Glycerin, Caprylhydroxamic Acid, Tocopherol, Beta-Sitosterol, Squalene, Aloe Barbadensis Leaf Juice2, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Isomalt, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Malus Domestica Fruit Cell Culture Extract, Aronia Melanocarpa Fruit Extract2, Camellia Sinensis Leaf Extract2, Euterpe Oleracea Fruit Extract2, Lycium Barbarum Fruit Extract2, Spirulina Maxima Extract, sr-Hydrozoan Polypeptide-1, Lecithin, Sodium Benzoate, Vitis Vinifera (Grape) Fruit Cell Extract, Potassium Sorbate.
PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton
INGREDIENTS AND APPEARANCE
| ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30
zinc oxide lotion |
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| Labeler - Andalou naturals (011472720) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bell International Laboratories | 967781555 | MANUFACTURE(55560-2201) | |