HYDRO ESSENCE BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide, octinoxate cream

Hydro Essence Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

Hydro Essence Broad Spectrum Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Private Label Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 10%

Octinoxate 7.5%

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 on a clean dry face, avoiding delicate eye area 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating. immediately after towel dryings 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 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 the product in this container from excessive heat and direct sun

Inactive ingredients

Water/Aqua/Eau, Oleth-3 Phosphate, Cyclopentasiloxane, Isopropyl Palmitate, Hydrogenated Soybean Oil, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Plankton Extract, Apple (Pyrus Malus) Fruit Extract, Hydroxyethyl, Oleth-10, Knot Grass (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Lecithin, Hydrogenated Soy Polyglycerides, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-450/50 Trimethylolpropane Lauryl Ether, PEG-7 Trimethylolpropane Coconut Ether, Disodium EDTA, Polyisobutene, Triethoxycaprylylsilane, 1,2 Hexanediol, C15-23 Alkane, Phenoxyethanol

SPL UNCLASSIFIED SECTION

brand MD

Zinc Oxide 10%
Octinoxate 7.5%
Knotweed

MEDICAL GRADE
SHIELD

RECOMMENDED FOR
COMBO  NORMAL
DRY        SENSITIVE

GREEN LEAF PROGRAM
NOT TESTED ON ANIMALS

Distributed by:
brandMD®
Canoga Park, CA 91304
(818) 534-3180
www.brandMD.com

Packaging

INGREDIENTS AND APPEARANCE

HYDRO ESSENCE BROAD SPECTRUM SUNSCREEN SPF 40 
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72957-008(NDC:39765-025)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
APPLE (UNII: B423VGH5S9)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
OLETH-10 (UNII: JD797EF70J)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C15-23 ALKANE (UNII: J3N6X3YK96)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72957-008-01	56 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

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

Labeler - Private Label Skin Care (116996962)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Skin Care		116996962	relabel(72957-008)