BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 17  VITAMIN C WITH COQ10- 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 17
Vitamin C with CoQ10

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

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
BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 17   VITAMIN C WITH COQ10
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76328-334
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE140 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76328-334-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201303/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/01/201303/19/2020
Labeler - Lotus Brands, Inc. (879022713)
Registrant - Sun Deep Inc. (189788201)
Establishment
NameAddressID/FEIBusiness Operations
Sun Deep Inc.189788201MANUFACTURE(76328-334)

Revised: 1/2022
Document Id: 580cb37b-ce5c-47c2-88bd-dc160e464df5
Set id: d0351dc8-7ae1-4f7d-93e2-c3e3bf60660f
Version: 3
Effective Time: 20220114
 
Lotus Brands, Inc.