Beauty Without Cruelty® - Broad Spectrum SPF 18

Drug Labeling and Warnings

Drug Details [pdf]

BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 18- octisalate, avobenzone, and octocrylene lotion 
Lotus Brands, 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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Beauty Without Cruelty® - Broad Spectrum SPF 18

Drug Facts:

Active ingredient

Octisalate 5.0%
Avobenzone 2.5%
Octocrylene 5.0%

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 liberally 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

Purified water, glycerin, Helianthus annuus (sunflower) seed oil1, Aloe barbadensis (aloe vera) leaf juice1, glyceryl stearate, ethyl hexyl palmitate, stearic acid, glyceryl monolaurate, magnesium ascorbyl phosphate, cetearyl alcohol, tocopherol acetate, tocopherols, Butyrospermum parkii (shea) butter, Macrocystis pyrifera (kelp) extract, squalane2, allantoin, panthenol, Anthemis nobilis (chamomile) extract1, Calendula officinalis (calendula) extract1, hyaluronic acid, sodium carbomer, Lavandula angustifolia (lavender) extract1, Arnica montana (arnica) extract1, Camellia sinensis (white tea) extract1, Rosa canina (rose hip) oil1, Linum usitatissimum (flax) seed oil1, Borago officinalis (borage) seed oil1, lecithin, Cocos nucifera (coconut) oil, phenoxyethanol, ethyl hexyl glycerin.

1 organic

2 Vegetable Source
18% Organic Content

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 1.800.824.6396 M-F 9-5 Central Time excluding weekends & holidays

Distributed by: Lotus Brands, Inc. 1100 Lotus Drive, Silver Lake, WI 53170 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

BWC
BEAUTY WITHOUT CRUELTY®

fragrance free

daily
facial lotion

broad spectrum
spf 18 sunscreen

benefits all skin types

provides
uva and uvb protection

• 100% Vegan—No Animal Ingredients
• No Animal Testing
• Aloe vera, Rosehips & Shea Butter
  moisturize, replenish & smooth skin
• May be used under makeup, alone
  or with your regular moisturizer

4 fl oz
118 ml e

BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 18 
octisalate, avobenzone, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76328-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL LAURATE (UNII: Y98611C087)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
SHEA BUTTER (UNII: K49155WL9Y)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
SQUALANE (UNII: GW89575KF9)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYALURONIC ACID (UNII: S270N0TRQY)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)
LINSEED OIL (UNII: 84XB4DV00W)
BORAGE SEED OIL (UNII: F8XAG1755S)
COCONUT OIL (UNII: Q9L0O73W7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76328-333-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2013	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2013	12/01/2016

Labeler - Lotus Brands, Inc. (879022713)

Registrant - Sun Deep Inc. (189788201)

Revised: 10/2019

Document Id: 92e328c2-b830-4fdc-9064-4004357597a8

34390-5

Set id: 44eeb921-c0e4-46c5-ab9e-467948dbf8fa

Version: 2

Effective Time: 20191004