DAILY DEFENSE ANTIOXIDANT DAY BROAD SPECTRUM SPF 30- octinoxate, octisalate, zinc oxide cream

Daily Defense Antioxidant Day Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Daily Defense Antioxidant Day Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Skin Actives Scientific, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredients:

Octinoxate  7.5%

Octisalate  4.0%

Zinc Oxide  2.5%

Sunburn Protection

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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:

• For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and consult physician

if irritation or rash developes.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

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 cream

Product 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)