Drug Labeling and Warnings

Drug Details [pdf]

DYNAMIC SKIN RECOVERY SPF30- avobenzone, octinoxate, octisalate, oxybenzone lotion 
PureTek Corporation

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.

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active ingredients:

Avobenzone (3.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (5.0%).

other ingredients:

Water (Aqua), Octyldodecyl Neopentanoate, Butylene Glycol, Pentylene Glycol, Arachidyl Alcohol, Behenyl Alcohol, Nylon-12, Leuconostoc/Radish Root Ferment Filtrate, Arginine/Lysine Polypeptide, Pamlitoyl Tripeptide-5, Camellia Sinensis Leaf Extract, Arachidyl Glycoside, Glycine Soja (Soybean) Protein, Sodium Hyaluronate, Saccharomyces Lysate Extract, Oenothera Biennis (Evening Primrose) Oil, Glucosamine HCl, Allantoin, Squalane, Algae Extract, Yeast Extract, Chrysanthemim Parthenium (Feverfew) Extract, Colloidal Oatmeal, Urea, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycerin, Disodium EDTA, Citronellol, Eugenol, Geraniol, Limonene, Linalool, Helianthus Annuus (Sunflower) Seed Oil, Rose Flower Oil, Citrus Medica Limonum (Lemon) Peel Oil, Pelargonium Graveolens Oil, Citrus Medica Limonum (Lemon) Peel Extract, Eugenia Caryophyllus (Clove) Flower Oil, Pelargonium Groveolens Flower Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Caprylic/Capric Triglyceride,Titanium Dioxide (Cl 77891).

directions:

Apply to face and neck, preferably 30 minutes prior to daylight exposure.

warnings:

For external use only, not to be swallowed. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Apply prior to sun exposure. Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner. Do not use on infants under 6 months old. Contains Oxybenzone.

Label

DYNAMIC SKIN RECOVERY SPF30 
avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-856
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ALLANTOIN (UNII: 344S277G0Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
SQUALANE (UNII: GW89575KF9)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
UREA (UNII: 8W8T17847W)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
OATMEAL (UNII: 8PI54V663Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
EUGENOL (UNII: 3T8H1794QW)
GERANIOL (UNII: L837108USY)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
LEMON OIL (UNII: I9GRO824LL)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
LEMON PEEL (UNII: 72O054U628)
CLOVE OIL (UNII: 578389D6D0)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ROSEWOOD OIL (UNII: F2522O5L7B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FEVERFEW (UNII: Z64FK7P217)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
ROSE OIL (UNII: WUB68Y35M7)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
LEMON (UNII: 24RS0A988O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-856-04	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2009	03/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2009	03/18/2019

Labeler - PureTek Corporation (785961046)

Revised: 3/2019

Document Id: a636df1a-9015-4bc1-a2e4-2fa1f94438cf

34390-5

Set id: c5ac541e-b532-4369-a87f-b6e6a5c171f6

Version: 3

Effective Time: 20190318