ROC - HYDRATION PLUS MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

RoC - Hydration Plus Moisturizer SPF 30 by

Drug Labeling and Warnings

RoC - Hydration Plus Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Roc Skincare, Dermaceutical Laboratories Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

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 For Sunscreen Use:

• Apply generously 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 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
• Children under 6 months of age: Ask a doctor

Other information

• Protect this product from excessive heat and direct sun

Inactive ingredients

Water/Aqua/Eau, Pentylene Glycol, Dimethicone, Octyldodecanol, Caprylyl Methicone, Propanediol, Hyaluronic Acid, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Biosaccharide Gum-4, Jasminum Sambac (Jasmine) Leaf Cell Extract, Glycerin, Dibutyl Lauroyl Glutamide, Carbomer, Aminomethyl Propanol, Dibutyl Ethylhexanoyl Glutamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylhydroxamic Acid, 1,2-Hexanediol, Disodium EDTA, Fragrance/Parfum.

Questions or Comments?

Call toll free 1-800-RoC-1964 (1-800-762-1964)

Carton Packaging

INGREDIENTS AND APPEARANCE

ROC - HYDRATION PLUS MOISTURIZER SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73496-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.5 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
OCTYLDODECANOL (UNII: 461N1O614Y)
PROPANEDIOL (UNII: 5965N8W85T)
HYALURONIC ACID (UNII: S270N0TRQY)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73496-012-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2025

Labeler - Roc Skincare (117157981)

Establishment
Name	Address	ID/FEI	Business Operations
Dermaceutical Laboratories Limited Liability Company		078457159	manufacture(73496-012)