Dynamic Sunscreen Broad Spectrum SPF 55 Sun Protection: Package Insert and Label Information

DYNAMIC SUNSCREEN BROAD SPECTRUM SPF 55 SUN PROTECTION- octinoxate and zinc oxide cream
J. Melvin Deese, Jr., M.D., P.C.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

ACTIVE INGREDIENTS

Octinoxate 7.5%

Zinc Oxide 4.8%

PURPOSE

Sunscreen

USES

Help prevent sunburn.

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 ask a doctor if rash or irritation occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply liberally and evenly 15 minutes before sun exposure. 1Reapply:

At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.

• 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 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-sleeve shirts, pants, hats, and sunglasses.

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1

For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

OTHER INFORMATION

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

Cool Blue Laser Aesthetics Dynamic Sunscreen Broad Spectrum SPF 55 Sun Protection 1.75 fl oz (50ml)

Cool Blue
​Laser Aesthetics
Dynamic Sunscreen Broad Spectrum SPF 55
Sun Protection
1.75 fl oz (50ml)

DYNAMIC SUNSCREEN BROAD SPECTRUM SPF 55 SUN PROTECTION octinoxate and zinc oxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82410-5550 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 48 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER ISOCETYL STEARATE SORBITOL CETOSTEARYL ALCOHOL CYCLOMETHICONE 5 GLYCERYL MONOSTEARATE PEG-100 STEARATE ALCOHOL OCTISALATE POLYOXYL 20 CETOSTEARYL ETHER .ALPHA.-TOCOPHEROL ACETATE VINYLPYRROLIDONE/EICOSENE COPOLYMER HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) ETHYLHEXYLGLYCERIN BETULA PUBESCENS BARK GARDEN CRESS SPROUT SAGE COLA ACUMINATA SEED CAMELLIA OLEIFERA LEAF ALOE VERA LEAF XANTHAN GUM ISOMALT EDETATE DISODIUM ANHYDROUS TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE CAPRYLYL GLYCOL PHENOXYETHANOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82410-5550-2 50 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/19/2021

Labeler — J. Melvin Deese, Jr., M.D., P.C. (084978393)

Revised: 11/2021 J. Melvin Deese, Jr., M.D., P.C.