NDC | 70249-707-01 |
Set ID | 41a0afe9-4c05-4f23-8893-07e374bc40f6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Skin Actives Scientific, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- DRUG FACTS:
- Active Ingredients:
- Uses:
-
Directions:
- Apply liberally 15-minutes before sun exposure.
- Reapply:
-At least every two hours.
-Immediately after swimming, sweating or towel drying.
SUN PROTECTION MEASURES: Spending time in the increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
-Limit time in the sun, especially between 10am and 2pm.
-Wear long sleeve shirts, pants, hats and sunglasses.
-For children under 6-months, consult a physician.
- Warnings:
-
Inactive Ingredients:
Aloe barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Astaxanthin, C13-14 Isoparaffin, Camellia sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Ferulic Acid, Glutaredoxin (sH-Polypeptide-77), Glycerin, Glyceryl Stearate SE, Sodium Hyaluronate, Lactobacillus/Kelp Ferment Filterate, Laureth-7, Lycopene, Cholesteryl Oleyl Carbonate (and) Cholesteryl Nonanoate (and) Cholesteryl Chloride (and) BHT, Mangiferin, Phenoxyethanol, polyacrylamide, Polysorbate-20, Prunus amygdalus dulcis (Sweet Almond) Oil, Punica granatum (Pomegranate) Extract, Sesamum indicum (Sesame) Seed Oil, Sodium PCA, Sorbitan Olivate, Squalane, Stearyl Alcohol, Superoxide Dismutase, Thioredoxin (sH-Polypeptide-2), Tocopherol, Tocotrienols, Lutein, Zemea Propanediol, Thioctic Acid, β-Carotene
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
DAILY DEFENSE ANTIOXIDANT DAY BROAD SPECTRUM SPF 30
octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70249-707 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) ASTAXANTHIN (UNII: 8XPW32PR7I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERULIC ACID (UNII: AVM951ZWST) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LAURETH-7 (UNII: Z95S6G8201) LYCOPENE (UNII: SB0N2N0WV6) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MANGIFERIN (UNII: 1M84LD0UMD) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALMOND OIL (UNII: 66YXD4DKO9) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) SESAME OIL (UNII: QX10HYY4QV) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SORBITAN OLIVATE (UNII: MDL271E3GR) SQUALANE (UNII: GW89575KF9) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) THIOREDOXIN (UNII: XJZ418133Z) TOCOPHEROL (UNII: R0ZB2556P8) TOCOTRIENOLS (UNII: KP2MW85SSQ) LUTEIN (UNII: X72A60C9MT) THIOCTIC ACID (UNII: 73Y7P0K73Y) .BETA.-CAROTENE (UNII: 01YAE03M7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70249-707-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/11/2015 Labeler - Skin Actives Scientific, LLC (033957260)