Benefit Weightless Moisture Face Moisturizer Broad Spectrum SPF 15 Sunscreen: Package Insert and Label Information

BENEFIT WEIGHTLESS MOISTURE FACE MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, homosalate and octocrylene lotion
Autumn Harp, 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.

Drug Facts

Active Ingredients

Octocrylene 4.00%

Homosalate 3.00%

Avobenzone 2.50%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions) , decreases the risk of skin cnacer 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.

Discontinue use and ask a doctor if rash occurs.

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

Directions

Apply generously and evenly every morning on cleansed face and neck 15 minutes before sun exposure

For sunscreen use:

  • 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, regulary 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
  • For use on children less than 6 months of age, consult a doctor.

Other information

  • ​​protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Diisopropyl Adipate, Neopentyl Glycol Diheptanoate, Glycerin, Ethylhexyl Palmitate, Polysilicone-11, Polymethyl Methacrylate, Cetearyl Alcohol, Pentylene Glycol, Dimethicone, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Glucoside, Camellia Japonica Seed Oil, Citrullus Lanatus (Watermelon) Fruit Extract, Chlorphenesin, Lens Esculenta (Lentil) Fruit Extract, Fragrance, Pyrus Malus (Apple) Fruit Extract, Xanthan Gum, Ethylhexylglycerin, Laureth-12, Sodium Lactate, Sodium PCA, Linalool, Aloe Barbadensis Leaf Juice, Potassium Sorbate, Sodium Benzoate, Hexyl Cinnamal, d-Limonene, BHT, Citric Acid, Cyclopentasiloxane, Cyclotetrasiloxane, Sodium Hydroxide, Citronellol, Benzyl Benzoate.

Questions or comments?

www.benefitcosmetics.com

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BENEFIT WEIGHTLESS MOISTURE FACE MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN
octocrylene, homosalate, avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0356
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 2.5 mg in 100 mg
HOMOSALATE (HOMOSALATE) HOMOSALATE 3 mg in 100 mg
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 4 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
PENTYLENE GLYCOL
CAMELLIA JAPONICA SEED OIL
POLY(METHYL METHACRYLATE; 450000 MW)
BENZYL SALICYLATE (SALICYLIC ACID)
LENTIL
ETHYLHEXYLGLYCERIN
SODIUM PYRROLIDONE CARBOXYLATE (PYRROLIDONE CARBOXYLIC ACID)
.ALPHA.-HEXYLCINNAMALDEHYDE
APPLE FRUIT OIL
SODIUM LACTATE
BUTYLATED HYDROXYTOLUENE
CYCLOMETHICONE 4
CITRONELLENE LACTONE
BENZYL BENZOATE
CITRAL
GERANIOL
SODIUM HYDROXIDE
ANHYDROUS CITRIC ACID
PHENOXYETHANOL
SODIUM BENZOATE
XANTHAN GUM
NEOPENTYL GLYCOL DIHEPTANOATE
LINALOOL, (+)-
LIMONENE, (+)-
FARNESOL
ETHYLHEXYL PALMITATE
CYCLOMETHICONE 5
DIISOPROPYL ADIPATE
ALOE VERA LEAF
GLYCERIN
POTASSIUM SORBATE
WATER
GLYCERYL STEARATE SE
PEG-100 STEARATE
CETEARYL GLUCOSIDE
DIMETHICONE 20
WATERMELON
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
CETOSTEARYL ALCOHOL
CHLORPHENESIN
LAURETH-12
ISOEUGENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51514-0356-1 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 50 mg in 1 BOTTLE, PUMP This package is contained within the CARTON (51514-0356-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2020
Labeler — Autumn Harp, Inc. (064187883)
Registrant — Autumn Harp, Inc. (064187883)
Establishment
Name Address ID/FEI Operations
Autumn Harp, Inc. 064187883 manufacture (51514-0356)

Revised: 03/2020 Autumn Harp, Inc.

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