NEPTUNE AVE. HIGH DIVE BARRIER REPAIR MOISTURIZER BROAD SPECTRUM SPF 50- avobenzone, octisalate, octocrylene cream

Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Neptune Ave. Inc., Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%
Octisalate 5%
Octocrylene 8%

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

Directions

For sunscreen use: Apply generously and evenly every 15 minutes before sun exposure. Apply to all skin exposed to the sun. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 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), Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Polyglyceryl-10 Myristate, Distarch Phosphate, Propanediol, Sorbitan Olivate, Cetearyl Olivate, Microcrystalline Cellulose, Diburyl Adipate, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Phenoxyethanol, Argania Spinosa (Argan) Kernel Oil, Cetearyl Alcohol, Tocopheryl Acetate (Vitamin E), Pentylene Glycol, Niacinamide, VP/Eicosene Copolymer, Coco-Glucoside, Pectin. Triheptanoin, Squalane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Centella Asiatica (Gotu Kola) Extract, Ceramide NG, C13-16 Isoalkane, Propylene Glycol, Saccharomyces/Rice Ferment Filtrate, Carthamus Tinctorius (Safflower) Seed Oil, Tetrahexyldecyl Ascorbate (Vitamin C), Hippophae Rhamnoides (Sea Buckthorn) Oil, Ethylhexylglycerin, Hydroxyethylcellulose,, Xanthan Gum, Glycerin, Bisabolol, Camellia Sinensis (Green Tea) Leaf Extract, Macrocystis Pyrifera (Kelp) Extract, Palmaria Palmata Extract, Laminaria Digitata (Algae) Extract, Sodium Hydroxide, Sodium Hyaluronate.

Questions?

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Principal Display Panel

Neptune Ave.

Kelp-Infused
Formulation

50 SPF

High Dive Barrier
Repair Moisturizer

Broad Spectrum SPF 50
Made with 50%
Recycled Plastic (PCR)

50 ml (1.7 fl oz)

INGREDIENTS AND APPEARANCE

NEPTUNE AVE. HIGH DIVE BARRIER REPAIR MOISTURIZER BROAD SPECTRUM SPF 50 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84869-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
NIACINAMIDE (UNII: 25X51I8RD4)
COCO-GLUCOSIDE (UNII: ICS790225B)
PALMARIA PALMATA (UNII: 7832HOY4ZQ)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
MACROCYSTIS PYRIFERA (KELP) (UNII: K31S3OG5C4)
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)
BISABOLOL (UNII: 24WE03BX2T)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
PECTIN (UNII: 89NA02M4RX)
CERAMIDE NG (UNII: C04977SRJ5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
RICE GERM (UNII: 7N2B70SFEZ)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
DISTARCH PHOSPHATE, CORN (UNII: JFB4DJZ8BR)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SQUALANE (UNII: GW89575KF9)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-10 MYRISTATE (UNII: Y9WL8QN3ZB)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84869-000-01	1 in 1 CARTON	01/22/2025
1		50 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	01/22/2025

Labeler - Neptune Ave. Inc. (119365416)

Registrant - Columbia Cosmetics Manufacturing, Inc. (068267863)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(84869-000)