Active Ingredients And Purpose
Active Ingredients
Zinc Oxide 22.40%
Purpose
Sunscreen
MOISTURIZER
- Manufacturer
- OXYGEN DEVELOPMENT, LLC
- Effective date
- 2021-03-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:38:49
Key Label Information#
Uses
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
Warnings
For external use only.
Directions And Dosage
Directions
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer an 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 10am-2pm wear long-sleeved shirts, pants hats and sunglasses Children under 6 months of age: Ask a doctor.
Other Label Information
Other Information
Proect this product from excessive heat and direct sun.
Inactive ingredients
Water(Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Males (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus(red Raspberry) Seed oil, Cocos Nucifera(Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum parkii nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra(Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xantham Gum, Octyldodecanol, Tapioca Startch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492).
Questions or comments?
Call toll free (877) 546-2582
Primary Package
7.5ml 61354-012-01
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-012-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-387f-0266-e053-dadaa90a7c1a | Self Reflect Probiotic Moisturizing Sunscreen Zinc Oxide Broad Spectrum SPF 32 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-012-01 | MOISTURIZER | 7.5 mg in 1 BOTTLE | CREAM | 7.5 | 1 | |
| 61354-012-01 | MOISTURIZER | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- MOISTURIZER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-012 | 61354-012-01 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| COCONUT ALKANES | 1E5KJY107T | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| APPLE | B423VGH5S9 | IACT |
| COCO GLUCOSIDE | ICS790225B | IACT |
| LACTOBACILLUS REUTERI | 9913I24QEE | IACT |
Complete SPL Sections#
Active Ingredients
Zinc Oxide 22.40%
Purpose
Sunscreen
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
For external use only.
Directions
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer an 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 10am-2pm wear long-sleeved shirts, pants hats and sunglasses Children under 6 months of age: Ask a doctor.
Other Information
Proect this product from excessive heat and direct sun.
Inactive ingredients
Water(Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Males (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus(red Raspberry) Seed oil, Cocos Nucifera(Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum parkii nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra(Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xantham Gum, Octyldodecanol, Tapioca Startch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492).
Questions or comments?
Call toll free (877) 546-2582
Primary Package
7.5ml 61354-012-01
Secondary Package
7.5ml 61354-012-01