Habit SPF 41: Package Insert and Label Information

HABIT SPF 41- octisalate, avobenzone, homosalate and octocrylene spray
Bell International Laboratories, 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.

Active Ingredient

Avobenzone 2.8%

Homosalate 9.8%

Octisalate 4.9%

Octocrylene 9.5%

Purpose

Sunscreen

Uses

Helps prevent sunurn

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 producty keep out of eyes. Rinse wtih water to remove.

Stop use and ask a doctor if rash occurs

Flammable. Keep away from fire or spark.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply generously 15 minutes before sun exposure

Reapply at least every 2 hours

Use a warer-resistant sunscreen if swimming or sweating

Reapply after swimming or sweating

Children under 6 monts-age: Ask a doctor

Sun Protection Meaures. 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 10a.m. — 2 p.m.

-wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

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

Inactive Ingredients

Alcohol Denat., Bisabolol, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Ether, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isononyl Isononanoate, Lavendula Augustifolia (Lavender) Oil, Pelargonium Graveolens Flower Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

package label

Artwork
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Artwork
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HABIT SPF 41
facial spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76150-261
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 4.9 g in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 2.8 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 9.8 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 9.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLOCTYL SALICYLATE
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)
DICAPRYLYL ETHER
PELARGONIUM GRAVEOLENS FLOWER OIL
LEVOMENOL
ROSEMARY
ETHYL FERULATE
ISONONYL ISONONANOATE
LAVENDER OIL
ALCOHOL
DIHEPTYL SUCCINATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76150-261-51 30 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2020
Labeler — Bell International Laboratories, Inc (967781555)

Revised: 12/2020 Bell International Laboratories, Inc

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