HYDRA SPF 34- homosalate, octyl salicylate, avobenzone stick

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredients

Homosalate 10.00%
Octyl Salicylate 5.00%
Avobenzone 3.00%

Purpose

Sunscreen

Uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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.

Directions

Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming sweating Immediately after towel drying At least every 2 hours Children under 6 months of age: Ask a doctor

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 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.

Inactive Ingredients

Caprylic/Capric Triglyceride, Coconut (Cocos Nucifera) Oil, Methyl Methacrylate Crosspolymer, Polyethylene, Dimethicone, Diethylhexyl Syringylidenemalonate, Nylon-12, Squalene, Aloe (Aloe Vera) Leaf Extract, Edelweiss (Leontopodium Nivale) Flower/Leaf Extract, Calendula (Calendula Officinalis) Flower Extract, Soybean (Glycine Soja) Oil, Rice (Oryza Sativa) Bran Extract, Polyglyceryl-3 Diisostearate, Stearalkonium Hectorite, Rice (Oryza Sativa) Extract, Rice (Oryza Sativa) Germ Extract, Sunflower (Helianthus Annuus) Extract, Propylene Carbonate, Rosemary (Rosmarinus Officinalis) Leaf Extract, Tocopherol, Sunflower (Helianthus Annuus) Seed Oil

Questions or comments?

Call 1-888-DRMTLGY

SPL UNCLASSIFIED SECTION

MEDICAL GRADE SKIN CARE

Broad Spectrum SPF 34 Sunscreen

Ultra-lightweight & non-greasy

Water resistant for 40 minutes

Manufactured in USA

Dist. by DRMTLGY, LLC.
Canoga Park, CA 91304
www.DRMTLGY.com

A convenient sunscreen stick that provides UVA/UVB broad-spectrum protection with the added benefits of antioxidants and soothing extracts. This 40-minute water-resistant formula is ideal for both active outdoor activities and daily use, ensuring your skin stays nourished and protected.

CRUELTY FREE

BACKED BY SCIENCE

DERMATOLOGIST RECOMMENDED

Packaging

INGREDIENTS AND APPEARANCE

HYDRA SPF 34 
homosalate, octyl salicylate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83286-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
NYLON-12 (UNII: 446U8J075B)
SQUALENE (UNII: 7QWM220FJH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SOYBEAN OIL (UNII: 241ATL177A)
RICE BRAN (UNII: R60QEP13IC)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
RICE GERM (UNII: 7N2B70SFEZ)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ROSEMARY (UNII: IJ67X351P9)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Product Characteristics
Color	yellow (Natural Beige Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83286-017-01	1 in 1 CARTON	01/01/2026
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2026

Labeler - Drmtlgy, LLC (094762235)