Beauty Without Cruelty® - Broad Spectrum SPF 30

Drug Labeling and Warnings

Drug Details [pdf]

BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 30- zinc oxide 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 30

Drug Facts:

Active ingredient

Zinc Oxide 20%

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

Aloe barbadensis (aloe vera) leaf juice1, ascorbic acid, capric caprylic triglycerides, dimethicone, ethyl hexyl glycerin, Helianthus annuus (sunflower) oil1, hyaluronic acid, magnesium sulfate, Olea europaea (olive) oil1, phenoxyethanol, polyglyceryl-4 isostearate, purified water, Ricinus communis (castor) seed oil, Simmondsia chinensis (jojoba) oil1, sorbitan stearate, tocopherols.

1 organic
30% 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 - 88 ml Bottle Label

BWC
BEAUTY WITHOUT CRUELTY®

SPF30

Broad Spectrum SPF 30
sunscreen

provides UVA and
UVB protection

• 100% Vegan-Vegetarian
• Cruelty-Free — No Animal Testing
• Absorbs Quickly and Completely
  without greasy residue or white
  film on the skin

3 fl oz
88 ml e

Vegan®
Made in USA

BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76328-332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TRICAPRILIN (UNII: 6P92858988)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYALURONIC ACID (UNII: S270N0TRQY)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76328-332-01	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2013	05/08/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2013	05/08/2014

Labeler - Lotus Brands, Inc. (879022713)

Registrant - Sun Deep Inc. (189788201)

Revised: 10/2019

Document Id: 91c74ecd-6bb5-4f6c-b16e-ee82a84d9352

34390-5

Set id: 7414cddd-c2e0-4b12-92b5-6325c48ccabc

Version: 2

Effective Time: 20191004