ULTRA REPLENISHING SUNSCREEN SPF 40- homosalate, octisalate, octocrylene, zinc oxyide cream cream

Ultra Replenishing Sunscreen SPF 40 by

Drug Labeling and Warnings

Ultra Replenishing Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by CosMedical Technologies, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 8%
Octisalate 5%
Octocrylene 5%
Zinc Oxide 8%

PURPOSE

Sunscreen

INACTIVE INGREDIENT

Water
C12-15 Alkyl Benzoate
Glycerin
Mica
Polyglyceryl-2 Stearate
Glyceryl Stearate
Steareth-21
Stearyl Alcohol
Dimethicone
Phenoxyethanol
Simmondsia Chinensis (Jojoba) Seed Oil
Steareth-2
Fructose
Cocos Nucifera (Coconut) Oil
Citric Acid
Ethylhexylglycerin
Hydroxyethylcellulose
Chlorphenesin
Hydrolyzed Rice Protein
Titanium Dioxide (CI 77891)
Tocopheryl Acetate
Kaempferia Galanga Root Extract
Aloe Barbadensis Leaf Juice
Sodium Phytate
Lavandula Angustifolia (Lavender) Oil
Withania Somnifera Flower Extract
Iron Oxide (CI 77492)
Iron Oxide (CI 77491)
Citrus Aurantium Dulcis (Orange) Peel Oil
Silica
Dimethylmethoxy Chromanol
Vanilla Planifolia Fruit Extract
Iron Oxide (CI 77499)

WARNINGS AND PRECAUTIONS

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

DOSAGE & ADMINISTRATION

Directions
Apply liberally and evenly 15 minutes before sun exposure.
Reapply: at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating.
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 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 Children under 6 months of age: Ask a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA REPLENISHING SUNSCREEN SPF 40 
homosalate, octisalate, octocrylene, zinc oxyide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70060-1901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
STEARETH-2 (UNII: V56DFE46J5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHYTATE SODIUM (UNII: 88496G1ERL)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARETH-21 (UNII: 53J3F32P58)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
VANILLA (UNII: Q74T35078H)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCONUT OIL (UNII: Q9L0O73W7L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
JOJOBA OIL (UNII: 724GKU717M)
FRUCTOSE (UNII: 6YSS42VSEV)
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
ORANGE OIL (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70060-1901-1	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/16/2019
2	NDC: 70060-1901-2	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	09/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/16/2019

Labeler - CosMedical Technologies, LLC (803898329)

Registrant - CosMedical Technologies, LLC (803898329)