HYDROPEPTIDE S.P.F. SUN PROTECTION FRIENDS- titanium dioxide, zinc oxide 
HydroPeptide LLC

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HydroPeptide S.P.F. Sun Protection Friends

Drug Facts

Active Ingredients

Titanium Dioxide 1.25%, Zinc Oxide 2.5%.

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

Warnings

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. Skin Cancer/Skin Aging Alert:

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

Drug Facts

Active Ingredients

Titanium Dioxide 2.5%, Zinc Oxide 6%

Sunscreen

Uses

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

Warnings

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. Skin Cancer/Skin Aging Alert:

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. • 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





Sun Protection Measures.

Inactive Ingredients

1,2-Hexanediol, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitride, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance (Parfum), Glycerin, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethiconez, Limonene, Linalool, Magnesium Stearate, Methyl Ionone, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Water (Aqua), Xanthan Gum, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsilozyethyl Hexyl Dimethicone, Tripeptide-1, Tripeptide-10 Citrulline, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

Other Information

Protect the products in this container from excessive heat and direct sun.

Questions or comments?

Call 1.800.932.9873

Package Labeling:

Main LabelInner Package2

IP1

HYDROPEPTIDE S.P.F. SUN PROTECTION FRIENDS 
titanium dioxide, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60934-010
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60934-010-001 in 1 KIT01/01/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 75 mL
Part 21 TUBE 15 mL
Part 1 of 2
HYDROPEPTIDE SOLAR DEFENSE HAND GUARD 
titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC:60934-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60934-011-001 in 1 CARTON
175 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2021
Part 2 of 2
HYDROPEPTIDE SOLAR DEFENSE TINTED 
titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC:60934-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BENZYL BENZOATE (UNII: N863NB338G)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BIOTIN (UNII: 6SO6U10H04)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHAMOMILE (UNII: FGL3685T2X)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CITRAL (UNII: T7EU0O9VPP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CUCUMBER (UNII: YY7C30VXJT)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ACAI (UNII: 46AM2VJ0AW)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYL IONONES (UNII: EL78BGX1LO)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
PREZATIDE (UNII: 39TG2H631E)  
TRIPEPTIDE-10 CITRULLINE (UNII: 2732R0E76W)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60934-012-001 in 1 CARTON
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2021
Labeler - HydroPeptide LLC (006297465)

Revised: 12/2023
Document Id: 0c83bd92-3b18-bc7b-e063-6294a90afa19
Set id: f3669a1e-8b75-4e94-a3f0-71dcbc3fa914
Version: 2
Effective Time: 20231214
 
HydroPeptide LLC