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NDC 60934-0011-00 HydroPeptide Solar Defense Hand Guard 12.5; 25 mg/mL; mg/mL Details

HydroPeptide Solar Defense Hand Guard 12.5; 25 mg/mL; mg/mL

HydroPeptide Solar Defense Hand Guard is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by HydroPeptide LLC. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	60934-0011
Product ID	60934-011_ce9d9647-0817-1467-e053-2995a90aede2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	HydroPeptide Solar Defense Hand Guard
Proprietary Name Suffix	n/a
Non-Proprietary Name	TITANIUM DIOXIDE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	12.5; 25
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	HydroPeptide LLC
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 60934-0011-00 (60934001100)

Pricing Information	N/A
NDC Package Code	60934-011-00
Billing NDC	60934001100
Package	1 TUBE in 1 CARTON (60934-011-00) / 75 mL in 1 TUBE
Marketing Start Date	2021-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1002ce35-e8ac-470f-8818-328a8068ccb1 Details

Drug Facts

Active Ingredients

Titanium Dioxide 1.25%, Zinc Oxide 2.5%.

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 product is swallowed, get medical help or contact a Poison Control Center right away.

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.

• Children under 6 months of age: Ask a doctor

Inactive Ingredients

Alumina, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Chondrus Crispus (Carrageenan), Cyclohexasiloxane, Cyclopentasiloxane, Glucose, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Isopropyl Myristate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Lecithin, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Pseudoalteromonas Ferment Extract, Sodium PCA, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsilozyethyl Hexyl Dimethicone, Tripeptide-1, Tripeptide-10 Citrulline, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

Package Labeling:

INGREDIENTS AND APPEARANCE

HYDROPEPTIDE SOLAR DEFENSE HAND GUARD

titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60934-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	12.5 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
CHLORPHENESIN (UNII: I670DAL4SZ)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
PREZATIDE (UNII: 39TG2H631E)
TRIPEPTIDE-10 CITRULLINE (UNII: 2732R0E76W)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60934-011-00	1 in 1 CARTON	01/01/2021
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2021

Labeler - HydroPeptide LLC (006297465)

Revised: 10/2021

Document Id: ce9d9647-0817-1467-e053-2995a90aede2

Set id: 1002ce35-e8ac-470f-8818-328a8068ccb1

Version: 1

Effective Time: 20211018