Supergoop! Daily Hydra-Ceramide Boost + SPF40

Supergoop Daily Hydra-Ceramide Boost SPF40 by

Drug Labeling and Warnings

Supergoop Daily Hydra-Ceramide Boost SPF40 by is a Otc medication manufactured, distributed, or labeled by HK Kolmar Canada, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPERGOOP DAILY HYDRA-CERAMIDE BOOST SPF40- avobenzone, homosalate, octisalate, octocrylene oil 
HK Kolmar Canada, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Supergoop! Daily Hydra-Ceramide Boost + SPF40

Drug Facts

Active Ingredients

Avobenzone 2%

Homosalate 9%

Octisalate 5%

Octocrylene 10%

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

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: Ask a doctor

Inactive Ingredients

Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Ether, Butyloctyl Salicylate, Polybutene, Ethyl Olivate, Rosa Canina Seed Oil, Jojoba Oil/Macadamia Seed Oil Esters, Hydrogenated Polycyclopentadiene, Squalane, Glycine Soja (Soybean) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Polyglyceryl-3 Diisostearate, Tocopherol, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Avena Sativa (Oat) Kernel Oil, Phytosteryl Macadamiate, Ceramide NP (Ceramide III B), Olea Europaea (Olive) Leaf Extract, Bacillus Ferment, Phytosterols, Ricinus Communis (Castor) Seed Oil, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Wax

Other Information

Protect the product in this container from excessive heat and direct sun

Questions or comments?

Contact our Sun Specialists 877-564-7330

Package Labeling:49354-125-30

Package Labeling:49354-125-05

SUPERGOOP DAILY HYDRA-CERAMIDE BOOST SPF40 
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49354-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ETHYL OLIVATE (UNII: KKJ108Y20W)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
SQUALANE (UNII: GW89575KF9)
SOYBEAN OIL (UNII: 241ATL177A)
JOJOBA OIL (UNII: 724GKU717M)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TOCOPHEROL (UNII: R0ZB2556P8)
RICE GERM (UNII: 7N2B70SFEZ)
OAT KERNEL OIL (UNII: 3UVP41R77R)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
CERAMIDE NP (UNII: 4370DF050B)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CASTOR OIL (UNII: D5340Y2I9G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49354-125-30	1 in 1 CARTON	09/01/2021
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 49354-125-05	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2021

Labeler - HK Kolmar Canada, Inc (243501959)

Revised: 7/2022

Document Id: e36c853e-15e2-6be2-e053-2a95a90afe36

34390-5

Set id: cd8b5d46-f3f8-9427-e053-2995a90a676a

Version: 2

Effective Time: 20220710