BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 17 VITAMIN C WITH COQ10- zinc oxide lotion

Beauty Without Cruelty - Broad Spectrum SPF 17 by

Drug Labeling and Warnings

Beauty Without Cruelty - Broad Spectrum SPF 17 by is a Otc medication manufactured, distributed, or labeled by Lotus Brands, Inc., Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:
Active ingredient

Zinc Oxide 14%
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, Aloe barbadensis (aloe vera) leaf juice1, capric caprylic triglycerides, sorbitan stearate, polyglyceryl-4 isostearate, dimethicone, Ricinus communis (castor) seed oil, magnesium sulfate, Helianthus annuus (sunflower) oil1, Simmondsia chinensis (jojoba) oil1, ascorbic acid, ubiquinone (CoQ10), Cucumis sativus (cucumber) extract1, Camellia sinensis (green tea) extract1, Anthemis nobilis (chamomile) extract1, Calendula officinalis (calendula) extract1, Lavandula angustifolia (lavender) extract1, Butyrospermum parkii (shea) butter1, panthenol, Rosa canina (rose hip) oil1, tocopherol, Olea europaea (olive) oil1, hyaluronic acid2, phenoxyethanol, ethyl hexyl glycerin

1 Organic 27% Organic Content

2 Vegetable Source

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

BWC
BEAUTY WITHOUT CRUELTY®

facial
moisturizer

VITAMIN C
with CoQ10

broad spectrum
spf 17 sunscreen

provides
uva and uvb protection

100% Vegan—No Animal Ingredients
No Animal Testing
Vitamin C and CoQ10 soothe & nourish skin
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

Principal Display Panel - 118 mL Bottle Label

INGREDIENTS AND APPEARANCE

BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 17 VITAMIN C WITH COQ10
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76328-334
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	140 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE (UNII: 92RU3N3Y1O)
CASTOR OIL (UNII: D5340Y2I9G)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
UBIDECARENONE (UNII: EJ27X76M46)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
SHEA BUTTER (UNII: K49155WL9Y)
PANTHENOL (UNII: WV9CM0O67Z)
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)
TOCOPHEROL (UNII: R0ZB2556P8)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYALURONIC ACID (UNII: S270N0TRQY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76328-334-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2013

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

Labeler - Lotus Brands, Inc. (879022713)

Registrant - Sun Deep Inc. (189788201)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Deep Inc.		189788201	MANUFACTURE(76328-334)